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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K131506
Device Name AIRWAY SUPPORT SYSTEM / AIRPORT
Applicant
ABEON MEDICAL CORPORATION
8000 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Applicant Contact ALLISON SLAGA
Correspondent
ABEON MEDICAL CORPORATION
8000 KATHERINE BOULEVARD
BRECKSVILLE,  OH  44141
Correspondent Contact ALLISON SLAGA
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/24/2013
Decision Date 03/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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