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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K883590
Device Name OXYTROL
Applicant
Cryogenic Assoc.
Interstate 575 & Airport Dr.
P.O. Box 1312
Canton,  GA  30114
Applicant Contact GREGORY G HELLMAN
Correspondent
Cryogenic Assoc.
Interstate 575 & Airport Dr.
P.O. Box 1312
Canton,  GA  30114
Correspondent Contact GREGORY G HELLMAN
Regulation Number868.5905
Classification Product Code
NFB  
Date Received08/22/1988
Decision Date 11/02/1988
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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