FDA 510(k) Application Details - K964429

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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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
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Regulation Number 886.5850

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Classification Product Code HQY
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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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