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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 K050153
Device Name SPIRIT, MODEL HAS
Applicant
CAIRE, INC.
1800 SANDY PLAINS INDUSTRIAL
PARKWAY, SUITE 316
MARIETTA,  GA  30066
Applicant Contact DAN CHLAN
Correspondent
CAIRE, INC.
1800 SANDY PLAINS INDUSTRIAL
PARKWAY, SUITE 316
MARIETTA,  GA  30066
Correspondent Contact DAN CHLAN
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received01/24/2005
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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