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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 K960890
Device Name SUNGLASSES OR MULTIPLE
Applicant
Outdoor Action Wear Specialties
141 W. Jackson Blvd.
Suite 2172
Chicago,  IL  60604
Applicant Contact LAURA SPINGOLA
Correspondent
Outdoor Action Wear Specialties
141 W. Jackson Blvd.
Suite 2172
Chicago,  IL  60604
Correspondent Contact LAURA SPINGOLA
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/05/1996
Decision Date 04/10/1996
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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