Cleared Traditional

WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

K003402 · Welcon, Inc. · General Hospital
May 2001
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K003402 is an FDA 510(k) clearance for the WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Welcon, Inc. (Ayer, US). The FDA issued a Cleared decision on May 1, 2001, 181 days after receiving the submission on November 1, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K003402 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2000
Decision Date May 01, 2001
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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