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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 K853043
Device Name 700-123 EYE SHADE
Applicant
Health Saver Products
P.O. Box 39
Grimsby
On Canada L3m 4gi,  CA
Applicant Contact MALONEY
Correspondent
Health Saver Products
P.O. Box 39
Grimsby
On Canada L3m 4gi,  CA
Correspondent Contact MALONEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/19/1985
Decision Date 12/13/1985
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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