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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K993773
Device Name HUMID-HEAT
Applicant
Hudson Rcj AB
6470 Riverview Terrace
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Hudson Rcj AB
6470 Riverview Terrace
Findley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/08/1999
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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