Cleared Traditional

K974758 - HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
(FDA 510(k) Clearance)

K974758 · Hydrox Laboratories · General Hospital
Mar 1998
Decision
80d
Days
Class 2
Risk

K974758 is an FDA 510(k) clearance for the HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K974758 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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