FDA 510(k) Application Details - K133413

Device Classification Name Light, Surgical, Accessories

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510(K) Number K133413
Device Name Light, Surgical, Accessories
Applicant BLACK DIAMOND VIDEO
503 CANAL BLVD.
RICHMOND, CA 94804 US
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Contact RAGUNATH MUNIANDY
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Regulation Number 878.4580

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Classification Product Code FTA
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Date Received 11/07/2013
Decision Date 01/07/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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