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FDA 510(k) Application Details - K955441
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K955441
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
ZONG RONG GLASSES LTD. CO.
1 FL., NO. 174
CHRONG-SHYUE RD.
TAINAN TW
Other 510(k) Applications for this Company
Regulation Number
886.5850
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Classification Product Code
HQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/21/1995
Decision Date
01/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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