Cleared Traditional

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

K872364 · Travenol Laboratories, S.A. · Gastroenterology & Urology

Oct 1987

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K872364 is an FDA 510(k) clearance for the HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309, a System, Dialysate Delivery, Sealed (Class II — Special Controls, product code FII), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on October 13, 1987, 117 days after receiving the submission on June 18, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K872364 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 1987
Decision Date	October 13, 1987
Days to Decision	117 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—