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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 K941576
Device Name SPECTACLE FRAMES/SUNGLASSES
Applicant
Sanders Optical Co., Inc.
6128 NW 11 St.
Sunrise,  FL  33313
Applicant Contact LEO SANDERS
Correspondent
Sanders Optical Co., Inc.
6128 NW 11 St.
Sunrise,  FL  33313
Correspondent Contact LEO SANDERS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/31/1994
Decision Date 06/03/1994
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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