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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 K920170
Device Name SPECTACLE FRAME
Applicant
Sciara Intl., Inc.
182-08 149th Ave.
Springfield Gardens,  NY  11413
Applicant Contact MARILYN MAHLER
Correspondent
Sciara Intl., Inc.
182-08 149th Ave.
Springfield Gardens,  NY  11413
Correspondent Contact MARILYN MAHLER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received01/13/1992
Decision Date 03/11/1992
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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