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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, liquid-oxygen, portable
510(k) Number K013251
Device Name SPIRIT 300
Applicant
CAIRE, INC.
3505 COUNTY RD. 42 WEST
BURNSVILLE,  MN  55306 -3803
Applicant Contact ROGER BRIESE
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received09/28/2001
Decision Date 12/18/2001
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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