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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K021357
Device Name MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
Applicant
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Applicant Contact HOWARD MERCER
Correspondent
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Correspondent Contact HOWARD MERCER
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received04/29/2002
Decision Date 08/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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