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FDA 510(k) Application Details - K092801
Device Classification Name
More FDA Info for this Device
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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