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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cystometric gas (carbon-dioxide) on hydraulic device
510(k) Number K902843
Device Name BIOSEARCH ANAL BIOFEEDBACK DEVICE
Applicant
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Applicant Contact JOHN CARSELLO
Correspondent
BIOSEARCH MEDICAL PRODUCTS, INC.
35 INDUSTRIAL PKWY.
P.O. BOX 1700
SOMERVILLE,  NJ  08876
Correspondent Contact JOHN CARSELLO
Regulation Number876.1620
Classification Product Code
FAP  
Date Received06/28/1990
Decision Date 09/14/1990
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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