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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K861162
Device Name LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
Applicant
Efop
B P 193
13268 Marseille Cedex 8
France,  FR
Applicant Contact CARREL.
Correspondent
Efop
B P 193
13268 Marseille Cedex 8
France,  FR
Correspondent Contact CARREL.
Regulation Number886.5844
Classification Product Code
HQG  
Date Received03/28/1986
Decision Date 06/09/1986
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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