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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 K940741
Device Name MOUNTAIN SHADES -NONPRESCRIPTION SUNGLASSES
Applicant
Mountain Shades, Inc.
P.O. Box 609
Vail,  CO  81658
Applicant Contact KEN FOX
Correspondent
Mountain Shades, Inc.
P.O. Box 609
Vail,  CO  81658
Correspondent Contact KEN FOX
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/17/1994
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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