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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 K902970
Device Name PRECISION MEDICAL DISPOSABLE HUMIDIFIER
Applicant
PRECISION MEDICAL, INC.
7285 PARK DR.
BATH,  PA  18014
Applicant Contact JOHN R SELADY
Correspondent
PRECISION MEDICAL, INC.
7285 PARK DR.
BATH,  PA  18014
Correspondent Contact JOHN R SELADY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/06/1990
Decision Date 08/14/1990
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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