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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medevac Use Oxygen Generator
510(k) Number K082829
Device Name AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
Applicant
Carleton Life Support Systems, Inc.
2734 Hickory Grove Rd.
Davenport,  IA  52804 -1203
Applicant Contact GARY BYRD
Correspondent
Carleton Life Support Systems, Inc.
2734 Hickory Grove Rd.
Davenport,  IA  52804 -1203
Correspondent Contact GARY BYRD
Regulation Number868.5440
Classification Product Code
OLF  
Date Received09/25/2008
Decision Date 12/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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