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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Generator, Oxygen, Portable
510(k) Number K902890
Device Name ASPEN 3 OXYGEN CONCENTRATOR
Applicant
Mountain Medical Equipment, Inc.
370 Seventeenth St.
P.O.Box 46506, Suite 700
Denver,  CO  80201
Applicant Contact TOD CUMPSON
Correspondent
Mountain Medical Equipment, Inc.
370 Seventeenth St.
P.O.Box 46506, Suite 700
Denver,  CO  80201
Correspondent Contact TOD CUMPSON
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/02/1990
Decision Date 07/19/1990
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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