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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 K863943
Device Name POREX(TM) EYE SPHERE IMPLANT
Applicant
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Applicant Contact HOWARD A MERCER,PHD
Correspondent
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Correspondent Contact HOWARD A MERCER,PHD
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received10/10/1986
Decision Date 02/27/1987
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
Recalls CDRH Recalls
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