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FDA 510(k) Application Details - K971462
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K971462
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
D.G. PROVE CO.
22 KEELUNG RD., #6, 7TH FL.,
SEC. 2
TAIPEI 110 TW
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Contact
ANNE DINE
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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
04/21/1997
Decision Date
07/01/1997
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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