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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, chin, internal
510(k) Number K952677
Device Name MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
Applicant
POREX SURGICAL, INC.
4715 ROOSEVELT HWY.
COLLEGE PARK,  GA  30349 -2417
Applicant Contact HOWARD MERCER
Correspondent
POREX SURGICAL, INC.
4715 ROOSEVELT HWY.
COLLEGE PARK,  GA  30349 -2417
Correspondent Contact HOWARD MERCER
Regulation Number878.3550
Classification Product Code
FWP  
Date Received06/12/1995
Decision Date 08/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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