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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 K930566
Device Name OPHTHALMIC FRAMES W/DEMO LENSES & CLIP ON SUNGLASS
Applicant
E.B. Brown Opticians
1549 E. 30th St.
Cleveland,  OH  44114
Applicant Contact STEPHAN A SCHLEIN
Correspondent
E.B. Brown Opticians
1549 E. 30th St.
Cleveland,  OH  44114
Correspondent Contact STEPHAN A SCHLEIN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received02/03/1993
Decision Date 02/16/1994
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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