Document NEpzp2vkgo7XO3wrk9qeoEzeb

4 September 23, 1993 Mr. Matt Nowland C.R. Bard, Inc. 200 Ames Pond Drive Tewksbury, MA 01876 SUBJECT: MAF Number Assigned: Date of Submission: Title of Submission Holder of Submission: Submitted Bv: Agent(s): MAF-489 Mav 27. 1992 Geon Resin 30 BFGoodrich BFGoodrich None Dear Mr. Nowland: This letter is the FDA's authority to refer to MAF 489 for the information contained therein on Geon Resin 30 in the review of any of your premarket approval applications (PMA's), investigational device exemptions (IDE's), premarket notification submissions, reclassification petitions, color additive petitions, or other submissions to the FDA. You should include the original copy of this letter in the original copy of your submission to the FDA in order that your submission will not be found deficient for the lack of authorization and to expedite processing. Any Geon Resin 30 supplied to you for this purpose will comply with the product specifications contained in MAF 489. Sincerely, THE BFGOODRICH COMPANY Connie N. Dillon Regulatory and Data System Specialist bcc: Tom W. Williams (OTM-d/5-375) 21721002 BFG16258