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FDA 510(k) Application Details - K971384
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
More FDA Info for this Device
510(K) Number
K971384
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
LONG IN TIME ENT. CO., LTD.
NO. 7 ALLEY 500 LN. 942 TAI
WAN RD., YUNG KANG HSIANG
TAINAN HSIEN TW
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Contact
PAUL LEE
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Regulation Number
886.5850
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Classification Product Code
HQY
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More FDA Info for this Product Code
Date Received
04/14/1997
Decision Date
07/01/1997
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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