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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 K936103
Device Name CROWN SUNGLASSES
Applicant
Capo, Inc.
P.O. Box 775 2 Sunshine Blvd.
Ormond Beach,  FL  32174
Applicant Contact RICHARD D BANKER
Correspondent
Capo, Inc.
P.O. Box 775 2 Sunshine Blvd.
Ormond Beach,  FL  32174
Correspondent Contact RICHARD D BANKER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/22/1993
Decision Date 04/29/1994
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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