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FDA 510(k) Application Details - K964429
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
More FDA Info for this Device
510(K) Number
K964429
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
TRADE RESOURCES LTD.
141 W. JACKSON BLVD.
SUITE 2172
CHICAGO, IL 60604 US
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Contact
LAURA SPINGOLA
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
11/05/1996
Decision Date
12/12/1996
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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