Cleared Traditional

K922440 - STERIKING, SEE & PEEL
(FDA 510(k) Clearance)

K922440 · Cox Sterile Products, Inc. · General Hospital

Sep 1994

Decision

857d

Days

Class 2

Risk

K922440 is an FDA 510(k) clearance for the STERIKING, SEE & PEEL. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT).

Submitted by Cox Sterile Products, Inc. (Dallas, US). The FDA issued a Cleared decision on September 26, 1994, 857 days after receiving the submission on May 22, 1992.

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

Submission Details

510(k) Number	K922440 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 1992
Decision Date	September 26, 1994
Days to Decision	857 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

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