Cleared Traditional

K072563 - MILTEX RIGID CONTAINER SYSTEMS
(FDA 510(k) Clearance)

K072563 · Miltex, Inc. · General Hospital

Feb 2008

Decision

154d

Days

Class 2

Risk

K072563 is an FDA 510(k) clearance for the MILTEX RIGID CONTAINER SYSTEMS, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on February 12, 2008, 154 days after receiving the submission on September 11, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K072563 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2007
Decision Date	February 12, 2008
Days to Decision	154 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