Cleared Traditional

K954185 - RE-BAG MULTI-USE POUCH, LARGE & SMALL
(FDA 510(k) Clearance)

K954185 · Miltex, Inc. · General Hospital

Dec 1995

Decision

89d

Days

Class 2

Risk

K954185 is an FDA 510(k) clearance for the RE-BAG MULTI-USE POUCH, LARGE & SMALL. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT).

Submitted by Miltex, Inc. (Great Neck, US). The FDA issued a Cleared decision on December 4, 1995, 89 days after receiving the submission on September 6, 1995.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K954185 FDA.gov
FDA Decision	Cleared SESK
Date Received	September 06, 1995
Decision Date	December 04, 1995
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850