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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conformer, ophthalmic
510(k) Number K972034
Device Name MEDPOR OCULAR CONFORMER
Applicant
POREX SURGICAL, INC.
500 BOHANNON RD.
FAIRBURN,  GA  30213
Applicant Contact HOWARD MERCER
Correspondent
POREX SURGICAL, INC.
500 BOHANNON RD.
FAIRBURN,  GA  30213
Correspondent Contact HOWARD MERCER
Regulation Number886.3130
Classification Product Code
HQN  
Date Received06/02/1997
Decision Date 01/20/1998
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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