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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 K942322
Device Name SUNGLASSES
Applicant
Suntory Industrial Co.
13f-1, 59, Sec.
Tun Hua S. Rd.
Taipei-104,  TW
Applicant Contact KRIS CHOW
Correspondent
Suntory Industrial Co.
13f-1, 59, Sec.
Tun Hua S. Rd.
Taipei-104,  TW
Correspondent Contact KRIS CHOW
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/13/1994
Decision Date 09/06/1994
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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