Cleared Traditional

LEG DRAINAGE BAG STRAP BK6011

K831553 · Fred Sammons, Inc. · Gastroenterology & Urology
Jun 1983
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K831553 is an FDA 510(k) clearance for the LEG DRAINAGE BAG STRAP BK6011, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 35 days after receiving the submission on May 12, 1983. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K831553 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 16, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNX — Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5250

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