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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 K934020
Device Name SUNGLASSES
Applicant
Sun Probe Enterprise Co., Ltd.
# 15 Ln. 306 Chung Cheng
S. Rd. Yung Kang Shan Tainan
Hsien, Taiwan, R.O.C.,  TW
Applicant Contact IRVING WU
Correspondent
Sun Probe Enterprise Co., Ltd.
# 15 Ln. 306 Chung Cheng
S. Rd. Yung Kang Shan Tainan
Hsien, Taiwan, R.O.C.,  TW
Correspondent Contact IRVING WU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/17/1993
Decision Date 01/06/1994
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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