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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K913419
Device Name REGENCY, COMPARE, SUN OPTICS SUNGLASSES
Applicant
Cliff Weil, Inc.
P.O. Box 427
Mechanicsville,  VA  23111
Applicant Contact JERRY SCHWARTZLOW
Correspondent
Cliff Weil, Inc.
P.O. Box 427
Mechanicsville,  VA  23111
Correspondent Contact JERRY SCHWARTZLOW
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/31/1991
Decision Date 02/12/1992
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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