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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 K801619
Device Name MIST2GEN TEMPTROL 10
Applicant
MISTOGEN EQUIPMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MISTOGEN EQUIPMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/15/1980
Decision Date 08/04/1980
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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