FDA 510(k) Application Details - K092801

Device Classification Name

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510(K) Number K092801
Device Name ABS BLOWER, ABS NOZZLE, MODEL 1001
Applicant NIMBIC SYSTEMS, LLC
4910 WRIGHT ROAD, SUITE 170
STAFFORD, TX 77477 US
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Contact SEAN SELF
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Regulation Number

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Classification Product Code ORC
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Date Received 09/11/2009
Decision Date 05/20/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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