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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 K881184
Device Name INTERTECH STERILE WATER FOR INHALATION
Original Applicant
DELMED, INC.
120 albany st.
p.o. box 2623
new brunswick,  NJ  08903
Original Contact ronald guido
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/21/1988
Decision Date 05/25/1988
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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