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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 K953627
Device Name NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES
Applicant
New Sun Optical Enterprise Co., Ltd.
# 105 Tzu Chang Rd.
Yung Kang Hsiang
Taiwan Hsien,  TW
Applicant Contact JUDY AWANA
Correspondent
New Sun Optical Enterprise Co., Ltd.
# 105 Tzu Chang Rd.
Yung Kang Hsiang
Taiwan Hsien,  TW
Correspondent Contact JUDY AWANA
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/31/1995
Decision Date 10/25/1995
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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