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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 K010902
Device Name MEDPOR QUAD MOTILITY IMPLANT
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 Received03/26/2001
Decision Date 06/19/2001
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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