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FDA 510(k) Application Details - K960650
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
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510(K) Number
K960650
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
SOLOVISION OPTICAL, INC.
2 N.E. 40TH ST.
2ND FLOOR
MIAMI, FL 33137 US
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LINDA RAMOS
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Regulation Number
886.5850
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Classification Product Code
HQY
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Date Received
01/01/1996
Decision Date
03/19/1996
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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