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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K091650
Device Name AXS-590 SERIES
Applicant
SWR INTERNATIONAL, LTD
161 LITTLE BAY ROAD
NEWINGTON,  NH  03801
Applicant Contact MARTIN J LEIGHTON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/09/2009
Decision Date 11/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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