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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 K033028
Device Name ANEFIN, MODEL 100
Applicant
Axon Medical
2355 S. 1170 W.
Suite D
Salt Lake City,  UT  84119
Applicant Contact JOSEPH ORR
Correspondent
Axon Medical
2355 S. 1170 W.
Suite D
Salt Lake City,  UT  84119
Correspondent Contact JOSEPH ORR
Regulation Number868.5430
Classification Product Code
CBN  
Subsequent Product Code
BYW  
Date Received09/26/2003
Decision Date 07/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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