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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 K942500
Device Name SUNGLASSES TOKYO BAY
Applicant
Tokyo Bay, Inc.
1809 Lyon St.
San Francisco,  CA  94115
Applicant Contact DORY ISAACS
Correspondent
Tokyo Bay, Inc.
1809 Lyon St.
San Francisco,  CA  94115
Correspondent Contact DORY ISAACS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/24/1994
Decision Date 07/12/1994
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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