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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 K943131
Device Name ORVIS POLARIZED BI-FOCALS
Applicant
The Orvis Co., Inc.
U.S. Rte. 7a
Manchester,  VT  05254
Correspondent
The Orvis Co., Inc.
U.S. Rte. 7a
Manchester,  VT  05254
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/29/1994
Decision Date 08/02/1994
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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