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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 K955695
Device Name PLASTIC FRAME, METAL FRAME, OPTICAL
Applicant
Dah Sing Trading Co.
Unit 901, 9/F., Fortune Comm.
Bldg., 362 Sha Tsui Rd.
Tsuen Wan,  HK
Applicant Contact LING TSANG
Correspondent
Dah Sing Trading Co.
Unit 901, 9/F., Fortune Comm.
Bldg., 362 Sha Tsui Rd.
Tsuen Wan,  HK
Correspondent Contact LING TSANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/13/1995
Decision Date 01/29/1996
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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