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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 K881802
Device Name ALPINE PORTABLE OXYGEN GENERATOR
Applicant
MOUNTAIN MEDICAL EQUIPMENT, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Applicant Contact JAMES W MORGAN
Correspondent
MOUNTAIN MEDICAL EQUIPMENT, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Correspondent Contact JAMES W MORGAN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/28/1988
Decision Date 07/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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