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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 K854514
Device Name AMBI-24 PH/PRESSURE MONITOR
Applicant
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Applicant Contact JOHN J SPIE
Correspondent
Biosearch Medical Products, Inc.
35 Industrial Pkwy.
P.O. Box 1700
Somerville,  NJ  08876
Correspondent Contact JOHN J SPIE
Regulation Number876.1400
Classification Product Code
FFT  
Date Received11/12/1985
Decision Date 02/24/1986
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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