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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K870257
Device Name POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T.
Applicant
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Applicant Contact HOWARD A MERCER,PHD
Correspondent
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Correspondent Contact HOWARD A MERCER,PHD
Date Received01/23/1987
Decision Date 02/24/1987
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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