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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 K955441
Device Name ZONG RONG SUNGLASSES
Applicant
ZONG RONG GLASSES LTD. CO.
1 FL., NO. 174
CHRONG-SHYUE RD.
TAINAN,  TW
Correspondent
ZONG RONG GLASSES LTD. CO.
1 FL., NO. 174
CHRONG-SHYUE RD.
TAINAN,  TW
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/21/1995
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
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