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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Non-Direct Patient Interface (Home-Use)
510(k) Number K852283
Device Name THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE
Applicant
Thermix, Inc.
6019 S. Ingleside Ave., Su 102
Chicago,  IL  60637
Applicant Contact DAVID G BOSTWICK
Correspondent
Thermix, Inc.
6019 S. Ingleside Ave., Su 102
Chicago,  IL  60637
Correspondent Contact DAVID G BOSTWICK
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received05/29/1985
Decision Date 07/30/1985
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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