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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 K943640
Device Name SUNGLASS CLIP
Applicant
Australian Optical Co., Inc.
1775 Universal Ave.
Suite 1620
Kansas City,  MO  64120
Applicant Contact SHARI DOWNING
Correspondent
Australian Optical Co., Inc.
1775 Universal Ave.
Suite 1620
Kansas City,  MO  64120
Correspondent Contact SHARI DOWNING
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/27/1994
Decision Date 09/14/1994
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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