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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 K863886
Device Name SPORTLIFE SUNWEAR
Applicant
North American Vacuum Coating Co.
190 Alpha Park
Cleveland,  OH  44143
Applicant Contact JOHN H WILSON
Correspondent
North American Vacuum Coating Co.
190 Alpha Park
Cleveland,  OH  44143
Correspondent Contact JOHN H WILSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/06/1986
Decision Date 01/20/1987
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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