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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
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