Cleared Traditional

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15

K871471 · Travenol Laboratories, S.A. · Gastroenterology & Urology
Jun 1987
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K871471 is an FDA 510(k) clearance for the CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on June 12, 1987, 59 days after receiving the submission on April 14, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K871471 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1987
Decision Date June 12, 1987
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FJI — Dialyzer, Capillary, Hollow Fiber
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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