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FDA 510(k) Application Details - K961034
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K961034
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
KYLIE ENTERPRISE CO. LTD.
MIN-LO ST., NO.3, 3RD. FL.,
ALLEY 8 LANE 31
YUNG-HO, TAIPEI HSIEN TW
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PETER LIAW
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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
03/11/1996
Decision Date
04/24/1996
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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