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FDA 510(k) Application Details - K973526
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K973526
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
PYRAMID HANDBAGS, INC.
100 W. 33RD ST., SUITE 800
NEW YORK, NY 10001 US
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Contact
JENNIFER EPSTEIN
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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
09/18/1997
Decision Date
10/16/1997
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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