Cleared Traditional

GAMBRO MULTIPURPOSE SYSTEM MPS-10

K881270 · Gambro, Inc. · Gastroenterology & Urology

Aug 1988

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K881270 is an FDA 510(k) clearance for the GAMBRO MULTIPURPOSE SYSTEM MPS-10, a System, Dialysate Delivery, Sealed (Class II — Special Controls, product code FII), submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on August 24, 1988, 153 days after receiving the submission on March 24, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K881270 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1988
Decision Date	August 24, 1988
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—