Cleared Traditional

STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

K994321 · Automatic Liquid Packaging, Inc. · General Hospital
Oct 2000
Decision
308d
Days
Class 2
Risk

About This 510(k) Submission

K994321 is an FDA 510(k) clearance for the STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on October 25, 2000, 308 days after receiving the submission on December 22, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K994321 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1999
Decision Date October 25, 2000
Days to Decision 308 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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