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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K895300
Device Name MULTIPLE MENTAL SPECTACLE FRAMES
Applicant
Optica Trade S.A.
373 Chestnut St.
San Carlos,  CA  94070
Applicant Contact KAPILA
Correspondent
Optica Trade S.A.
373 Chestnut St.
San Carlos,  CA  94070
Correspondent Contact KAPILA
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/25/1989
Decision Date 09/21/1989
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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