Cleared Traditional

STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION

K973734 · Welcon, Inc. · General Hospital
Feb 1998
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K973734 is an FDA 510(k) clearance for the STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on February 5, 1998, 128 days after receiving the submission on September 30, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K973734 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1997
Decision Date February 05, 1998
Days to Decision 128 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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