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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 K884084
Device Name PORTABLE OXYGEN GENERATOR
Applicant
MOUNTAIN MEDICAL EQUIPMENT, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Applicant Contact SARA E JARDINICO
Correspondent
MOUNTAIN MEDICAL EQUIPMENT, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Correspondent Contact SARA E JARDINICO
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/27/1988
Decision Date 11/21/1988
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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