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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K924684
Device Name MICROFLOW
Applicant
MOUNTAIN MEDICAL EQUIPMENT, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Applicant Contact JOHN K ETTER
Correspondent
MOUNTAIN MEDICAL EQUIPMENT, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Correspondent Contact JOHN K ETTER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/16/1992
Decision Date 12/15/1992
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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