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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 K872929
Device Name PH MONITORING SYSTEM
Applicant
Sensatronix Medical Systems, Inc.
P.O. Box 376
So. Plainfield,  NJ  07080
Applicant Contact ALBERTO VELEZ
Correspondent
Sensatronix Medical Systems, Inc.
P.O. Box 376
So. Plainfield,  NJ  07080
Correspondent Contact ALBERTO VELEZ
Regulation Number876.1400
Classification Product Code
FFT  
Date Received07/27/1987
Decision Date 08/10/1987
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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