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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K092031
Device Name VAPOR-CLEAR, MODEL 100
Applicant
AXON MEDICAL, INC.
2645 SACKETT DR.
PARK CITY,  UT  84098
Applicant Contact JOSEPH ORR
Correspondent
AXON MEDICAL, INC.
2645 SACKETT DR.
PARK CITY,  UT  84098
Correspondent Contact JOSEPH ORR
Regulation Number868.5430
Classification Product Code
CBN  
Date Received07/06/2009
Decision Date 04/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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