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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 K962944
Device Name TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
Applicant
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Applicant Contact LEWIS W WARD
Correspondent
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Correspondent Contact LEWIS W WARD
Regulation Number868.5905
Classification Product Code
NFB  
Date Received07/26/1996
Decision Date 10/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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