Cleared Traditional

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG

K973364 · Maersk Medical A/S · Gastroenterology & Urology
Mar 1998
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K973364 is an FDA 510(k) clearance for the 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Maersk Medical A/S (Harlev, DK). The FDA issued a Cleared decision on March 17, 1998, 190 days after receiving the submission on September 8, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K973364 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1997
Decision Date March 17, 1998
Days to Decision 190 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

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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