Cleared Traditional

HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE

K974759 · Hydrox Laboratories · General Hospital
Mar 1998
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K974759 is an FDA 510(k) clearance for the HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Hydrox Laboratories (Elgin, US). The FDA issued a Cleared decision on March 9, 1998, 80 days after receiving the submission on December 19, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K974759 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1997
Decision Date March 09, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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