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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 K941767
Device Name FRAMES - VARIOUS BRAND NAMES
Applicant
Lenscraft, Inc.
8650 Governor'S Hill Dr.
P.O. Box 429580
Cincinnati,  OH  45242
Applicant Contact CYNTHIA L DILLON
Correspondent
Lenscraft, Inc.
8650 Governor'S Hill Dr.
P.O. Box 429580
Cincinnati,  OH  45242
Correspondent Contact CYNTHIA L DILLON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received04/11/1994
Decision Date 06/03/1994
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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