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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 K931431
Device Name FLOATER SUNGLASSES
Applicant
Floater Eyewear, Inc.
6924 Plainfield Rd.
Cincinnati,  OH  45236
Applicant Contact CLIFFORD A YORK
Correspondent
Floater Eyewear, Inc.
6924 Plainfield Rd.
Cincinnati,  OH  45236
Correspondent Contact CLIFFORD A YORK
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/22/1993
Decision Date 10/01/1993
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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