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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
Applicant
Delmed, Inc.
120 Albany St.
P.O. Box 2623
New Brunswick,  NJ  08903
Applicant Contact RONALD GUIDO
Correspondent
Delmed, Inc.
120 Albany St.
P.O. Box 2623
New Brunswick,  NJ  08903
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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