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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K770984
Device Name TA-2 TEMPERATURE ALARM
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 Number868.5270
Classification Product Code
BZE  
Date Received05/31/1977
Decision Date 07/05/1977
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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