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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ph, Stomach
510(k) Number K891410
Device Name NASOGASTRIC PH SUCTION CATHETER, ST-5001
Applicant
Sensatronix Medical Systems, Inc.
P.O. Box 376
So. Plainfield,  NJ  07080
Applicant Contact SIPE, PHD
Correspondent
Sensatronix Medical Systems, Inc.
P.O. Box 376
So. Plainfield,  NJ  07080
Correspondent Contact SIPE, PHD
Regulation Number876.1400
Classification Product Code
FFT  
Date Received03/14/1989
Decision Date 06/23/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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