Cleared Traditional

COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA

K822386 · Hospal Medical Corp. · Gastroenterology & Urology
Oct 1982
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K822386 is an FDA 510(k) clearance for the COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA, a System, Dialysate Delivery, Sealed (Class II — Special Controls, product code FII), submitted by Hospal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1982, 58 days after receiving the submission on August 9, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number K822386 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1982
Decision Date October 06, 1982
Days to Decision 58 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FII — System, Dialysate Delivery, Sealed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5860