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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Contact 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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