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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 K913640
Device Name DR. DEAN EDELL SOLARBLOC SUNGLASSES
Applicant
Cable Car Sunglasses
1700 Shelton Dr.
Hollister,  CA  95023
Applicant Contact PAUL MACWILLIAMSON
Correspondent
Cable Car Sunglasses
1700 Shelton Dr.
Hollister,  CA  95023
Correspondent Contact PAUL MACWILLIAMSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/14/1991
Decision Date 10/21/1991
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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