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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 K914473
Device Name SUNTIGER/EAGLE 475/AVIAN-AVIAN/PST 475 SUNGLASSES
Applicant
Biomedical Optics Co. of America, Inc.
7047 Radford Ave.
N. Hollywood,  CA  91605
Applicant Contact ALAN J MITTELMAN
Correspondent
Biomedical Optics Co. of America, Inc.
7047 Radford Ave.
N. Hollywood,  CA  91605
Correspondent Contact ALAN J MITTELMAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/08/1991
Decision Date 08/05/1992
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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