Cleared Traditional

LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET

K873435 · Level 1 Technologies, Inc. · Gastroenterology & Urology
Oct 1987
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K873435 is an FDA 510(k) clearance for the LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Level 1 Technologies, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 5, 1987, 40 days after receiving the submission on August 26, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K873435 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1987
Decision Date October 05, 1987
Days to Decision 40 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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