FDA 510(k) Application Details - K101496

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K101496
Device Name Light, Surgical, Fiberoptic
Applicant SENSORMED
2450 EJ CHAPMAN DR., SUITE 104
KNOXVILLE, TN 37996 US
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Contact WILLIAM MILAM
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 06/01/2010
Decision Date 09/14/2010
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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