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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 K940592
Device Name SUNGLASSES
Applicant
Sunblue Intl., Inc.
5f-5, # 250, Sec. 4
Chung Hsiao E. Rd.
Taipei, Taiwan, R.O.C.,  TW
Applicant Contact CHEN-KUN SHLH
Correspondent
Sunblue Intl., Inc.
5f-5, # 250, Sec. 4
Chung Hsiao E. Rd.
Taipei, Taiwan, R.O.C.,  TW
Correspondent Contact CHEN-KUN SHLH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/08/1994
Decision Date 06/30/1994
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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