FDA 510(k) Application Details - K963284

Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)

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510(K) Number K963284
Device Name Sunglasses (Non-Prescription Including Photosensitive)
Applicant RAVEN EYE, INC.
3333 EARHART, SUITE 200
CARROLLTON, TX 75006 US
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Contact ROBERT COOK
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Regulation Number 886.5850

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Classification Product Code HQY
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Date Received 07/29/1996
Decision Date 08/26/1996
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

FDA Source Information for K963284


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