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FDA 510(k) Application Details - K971495
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K971495
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
COIL
1314 NORTH HUNTER ST.
SUITE 202
BALTIMORE, MD 21202 US
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Contact
E.J. Smith
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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
04/24/1997
Decision Date
05/29/1997
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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