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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 K932151
Device Name FLOATS SUNGLASSES
Applicant
FLOATS, INC.
1515 CLEVELAND RD.
MIAMI BEACH,  FL  33141
Applicant Contact RAFAEL EGOZI
Correspondent
FLOATS, INC.
1515 CLEVELAND RD.
MIAMI BEACH,  FL  33141
Correspondent Contact RAFAEL EGOZI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/04/1993
Decision Date 01/03/1994
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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