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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 K920211
Device Name SUN/SPORTGLASSES
Applicant
Bacou USA, Inc. and Uvex Safety, Inc.
10 Thurber Blvd.
Smithfield,  RI  02917
Applicant Contact STEVEN P TOLISANO
Correspondent
Bacou USA, Inc. and Uvex Safety, Inc.
10 Thurber Blvd.
Smithfield,  RI  02917
Correspondent Contact STEVEN P TOLISANO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/16/1992
Decision Date 05/01/1992
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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