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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Orbital, Extra-Ocular
510(k) Number K863946
Device Name POREX(TM) EXTRA-OCULAR ORBITAL 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 Number886.3340
Classification Product Code
HQX  
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
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