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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K940095
Device Name FOX EYE ALUMINUM SHIELD, OPHTHALMIC
Applicant
P.J. Products, Inc.
8535 W. Bellfort
Houston,  TX  77071
Applicant Contact JOEL H GOFFMAN, M.D.
Correspondent
P.J. Products, Inc.
8535 W. Bellfort
Houston,  TX  77071
Correspondent Contact JOEL H GOFFMAN, M.D.
Regulation Number886.4750
Classification Product Code
HOY  
Date Received01/07/1994
Decision Date 03/01/1994
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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