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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 K123006
Device Name AIR BARRIER SYSTEM (ABS)
Applicant
Nimbic Systems, Inc.
11874 S. Evelyn Circle
Houston,  TX  77477 -3404
Applicant Contact HARVEY KNAUSS
Correspondent
Nimbic Systems, Inc.
11874 S. Evelyn Circle
Houston,  TX  77477 -3404
Correspondent Contact HARVEY KNAUSS
Regulation Number878.5070
Classification Product Code
ORC  
Date Received09/27/2012
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Clinical Trials NCT01559506
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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