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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 K862042
Device Name SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER
Applicant
ASSOCIATED MILLS, INC.
165 NORTH CANAL ST.
CHICAGO,  IL  60606
Applicant Contact JOHN JIAMBALVO
Correspondent
ASSOCIATED MILLS, INC.
165 NORTH CANAL ST.
CHICAGO,  IL  60606
Correspondent Contact JOHN JIAMBALVO
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received05/28/1986
Decision Date 06/05/1986
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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