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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 K871661
Device Name WH150 ROOM 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 Received04/28/1987
Decision Date 06/15/1987
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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