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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 K863556
Device Name CSI LIQUID OXYGEN SYSTEM
Applicant
Cryogenic Services, Inc.
Interstate 575 & Airport Dr.
P.O. Box 1312
Canton,  GA  30114
Applicant Contact GREGORY G HELLMANN
Correspondent
Cryogenic Services, Inc.
Interstate 575 & Airport Dr.
P.O. Box 1312
Canton,  GA  30114
Correspondent Contact GREGORY G HELLMANN
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received09/12/1986
Decision Date 10/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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