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FDA 510(k) Application Details - K964082
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K964082
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
NEO VU, INC.
122 WEST 27TH ST.
NEW YORK, NY 10001 US
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Contact
LUHSIG
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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
10/11/1996
Decision Date
11/25/1996
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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