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FDA 510(k) Application Details - K971104
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K971104
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
DELAGAR DIVISION BELCAM, INC.
27 MONTGOMERY ST.
ROUSES POINT, NY 12979-0277 US
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Contact
CALLY LUNETTA
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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
03/26/1997
Decision Date
05/06/1997
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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