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FDA 510(k) Application Details - K954419
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
More FDA Info for this Device
510(K) Number
K954419
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
AMI FASHION
501-4 NOWON 3KA, BUK GU
DAEGU 702-816 KR
Other 510(k) Applications for this Company
Contact
HYUN JOO CHOI
Other 510(k) Applications for this Contact
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
09/21/1995
Decision Date
05/16/1996
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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