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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 K936004
Device Name OPTICAL FRAMES
Applicant
Europa Continental, Inc.
56 Fuhrman Ave.
Ramsey,  NJ  07446
Applicant Contact SANG K HAN
Correspondent
Europa Continental, Inc.
56 Fuhrman Ave.
Ramsey,  NJ  07446
Correspondent Contact SANG K HAN
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received12/15/1993
Decision Date 02/22/1994
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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