Document GgEv6pnqYyLX867jEyeaVKKY

DEPARTMENT OF HEALTH & HUMAN SERVICES OCT 0 3.WT' Public Health Service MAF-379 SEP 2 5 Food and Drug Administration 1390 Piccard Drive Robert K. Hinderer, Ph.D. Manager, Health and Toxicology Environment, Health and Safety Management Systems The BFGoodrich Company 3925 Embassy Parkway Akron, Ohio 44313-1799 Dear Dr. Hinderer: This acknowledges Receipt of your submission dated August 13, 1991 pertaining to Geon 86155 Transparent 0027. This material Is retained as a Master File for a device, and It has been assigned the number MAF-379. You may amend this master file to include additional Information at any time. All amendments shall be submitted In duplicate, identified with the above MAF number, and addressed to: Food and Drug Administration Center for Devices and Radiological Health PMA Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, Maryland 20850 Information in your MAF may be incorporated by your client in their premarket approval applications (PMAs), investigational device exemptions (IDEs), premarket notification submissions, reclassification petitions, color additive petitions or other submissions to FDA. Reference to your MAF can only be authorized by you. In order that your client's submission will not be found deficient for lack of an authorizing letter and to expedite processing, please provide it directly to your client with the instruction that the original of your letter be included in the original copy of the client's submission along with a copy in each additional copy. Under this approach your MAF need not be amended to include the letter of authorization. If you require assistance regarding device master files procedures, you may contact the Premarket Approval (PMA) Section at (301) 427-1186. Sincerely yours, Mary Jd Robinson Assistant to the Director Premarket Approval Section Center for Devices and Radiological Health BFG21243 T