Cleared Traditional

DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST

K913736 · Biosearch Medical Products, Inc. · Gastroenterology & Urology
Feb 1992
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K913736 is an FDA 510(k) clearance for the DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on February 7, 1992, 171 days after receiving the submission on August 20, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.

Submission Details

510(k) Number K913736 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1991
Decision Date February 07, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1620

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