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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 K943275
Device Name MEDPOR SURGICAL IMPLANT MATERIAL
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 Number886.3320
Classification Product Code
HPZ  
Date Received07/07/1994
Decision Date 09/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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