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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K844778
Device Name SUNGLASSES
Applicant
B & M Sporting Goods, Inc.
121 NE 9th St.
Miami,  FL  33132
Correspondent
B & M Sporting Goods, Inc.
121 NE 9th St.
Miami,  FL  33132
Regulation Number886.5844
Classification Product Code
HQG  
Date Received12/10/1984
Decision Date 01/04/1985
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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