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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 K954939
Device Name MEDPOR OCULAR SCREW & ACCESSORIES
Applicant
POREX SURGICAL, INC.
4715 ROOSEVELT HWY.
COLLEGE PARK,  GA  30349 -2417
Applicant Contact HOWARD A MERCER
Correspondent
POREX SURGICAL, INC.
4715 ROOSEVELT HWY.
COLLEGE PARK,  GA  30349 -2417
Correspondent Contact HOWARD A MERCER
Regulation Number886.3320
Classification Product Code
HPZ  
Subsequent Product Code
HQH  
Date Received10/30/1995
Decision Date 01/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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