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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air Filter Portable Apparatus
510(k) Number K092801
Device Name ABS BLOWER, ABS NOZZLE, MODEL 1001
Applicant
Nimbic Systems, LLC
4910 Wright Rd. Suite 170
Stafford,  TX  77477
Applicant Contact SEAN SELF
Correspondent
Nimbic Systems, LLC
4910 Wright Rd. Suite 170
Stafford,  TX  77477
Correspondent Contact SEAN SELF
Regulation Number878.5070
Classification Product Code
ORC  
Date Received09/11/2009
Decision Date 05/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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