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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 K071335
Device Name MEDPOR ATTRACTOR IMPLANT
Applicant
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Applicant Contact JERRI L DAVIS
Correspondent
POREX SURGICAL, INC.
15 DART RD.
NEWNAN,  GA  30265
Correspondent Contact JERRI L DAVIS
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received05/11/2007
Decision Date 08/08/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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