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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 K864127
Device Name MECHANICAL OXYGEN REGULATOR
Applicant
Travomed, Inc.
2950 S. Umatilla St.
Englewood,  CO  80110
Applicant Contact DAVID SANSO
Correspondent
Travomed, Inc.
2950 S. Umatilla St.
Englewood,  CO  80110
Correspondent Contact DAVID SANSO
Regulation Number868.5905
Classification Product Code
NFB  
Date Received10/21/1986
Decision Date 11/13/1986
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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