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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 K943161
Device Name ORVIS DRIVING GLASSES
Applicant
THE ORVIS CO., INC.
U.S. ROUTE 7A
MANCHESTER,  VT  05254
Applicant Contact TOM MCMILLEN
Correspondent
THE ORVIS CO., INC.
U.S. ROUTE 7A
MANCHESTER,  VT  05254
Correspondent Contact TOM MCMILLEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/01/1994
Decision Date 08/04/1994
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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