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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 K850074
Device Name ESOPHOGEAL PH CATHETER
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Applicant Contact VELEZ CQE
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Correspondent Contact VELEZ CQE
Regulation Number876.1400
Classification Product Code
FFT  
Date Received01/09/1985
Decision Date 02/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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