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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 K792620
Device Name NEONATAL HEATED HUMIDIFIER
Applicant
MODERN MEDICAL SYSTEMS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MODERN MEDICAL SYSTEMS CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/19/1980
Decision Date 01/24/1980
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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