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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 K935678
Device Name SUNGLASS FRAME
Applicant
AUSTRALIAN OPTICAL CO., INC.
1775 UNIVERSAL AVE.
SUITE 1620
KANSAS CITY,  MO  64120
Applicant Contact DEBRA L ALDRIDGE
Correspondent
AUSTRALIAN OPTICAL CO., INC.
1775 UNIVERSAL AVE.
SUITE 1620
KANSAS CITY,  MO  64120
Correspondent Contact DEBRA L ALDRIDGE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/26/1993
Decision Date 02/16/1994
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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