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The BFGoodrich Company Geon Vinyl Division
6100 OakTree Boulevard Cleveland, Ohio 44131 216-447-6000
February 23, 1993
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Carol Ruffner Preferred Technologies PIainwell, MI Fax: 616/685-1148
SUBJECT: GEON 87718-004
Dear Ms. Ruffner:
Based on my review of the formulation for Geon 87718-004, all of the ingredients meet the current FDA requirements for use in contact with food. The ingredients are either listed under 21CFR Parts 172 through 184, or are prior sanctioned for use in food contact applications.
The final food contact article is subject to the following limitations:
1. Excluding food with alcohol content >8% under conditions of use of E, F, and G described in Table 2 in 21CFR 175.300(d);
2. For use in contact with food of types I, II, III, IV (except liquid milk), V, VI (except malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX described in Table 1 of 21CFR 176.170(c); and
3. The final food contact article must meet the extractive limitations imposed by 21CFR 178.3790.
If you have any questions, please contact me at 216/447-7831.
Sincerely,
THE BFGOODRICH COMPANY
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Connie N. Dillon Regulatory and Data System Specialist
0223-3jp
bcc: Rich Kruszynski Mary Beth Martineau - pieth
BFG16070
21631001
FACSIMILE MESSAGE
BFGOODRICH COMPANY 6100 OAK TREE BOULEVARD
CLEVELAND. OHIO 44131 .
-TEL.: (216) 447-6517 FAX: (216) 447-6459
OATE: OEUVER TO:
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FROM:
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MESSAGE:
Total number of pages
including this cover letter. If all pages have not been
received, please call Joanne Paige at 216/447-6278.
{.
BFG16071
FACSIMILE MESSAGE
BFGOODRICH COMPANY 6100 OAK TREE BOULEVARD
CLEVELAND. OHIO 44131 .
-TEL: (216) 447-6517 FAX: (216) 447-6459
DATE: ,, DELIVER TO:
FROM:
TIME:
i/C-Ar5-//</Z
.
MESSAGE:
Total number of pagesincluding this cover letter. If all pages have not been
received, please call Joanne Paige at 216/447-6278.
**
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BFG16072
INTEROFFICE MEMORANDUM
Date: From:
Dept: Tel No:
18-Feb-1993 09:53am EDT KRUSZYNSKIR
KRUSZYNSKIR@MRGATE@CLE
TO: DILLON, CONNIEA1 TO: RAMBASEK, TOM0A1 TO: MITCHELL, LANCE0A1 TO: MARTINEAU-PIELA, MARY BETH0A1
Subject: HOT LEAD1!!!
Lead Type: GENERAL INQUIRY
Leadno: 002176
Date:02151993
Contact: CAROL RUFFNER
Phone: 6166855873
Ext: 0000
Company: PREFERRED TECHNOLOGIES
Address: XXXXXXXXX
City: PLAINWELL
State: MI
Zip:XXXX
Business: E
Bus Segment: CUSTOM PROFILES
Bus Mgr: 21F
Market: CUSTOM PROFILES
Product: RIGID EXTRUSION
Application: MEDICAL FEEDER TUBES
Action taken: REFERRED"" CUSTOMER'S FDA INQUIRY TO TOXICOLOGY GROUP.
Details: CAROL RUFFNER HAS REQUESTED A COPY OF THE FDA APPROVAL LETTER
1 87718 TRANS. DISCUSSED WITH TOXICOLOGY GROUP FOR FOLLOW UP.
APPLICATION IS FOR HOSPITAL FEEDING TUBES.
21691004
BFG16073
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