Cleared Traditional

DISINFECTION WITH THE COX DRY HEAT STERILIZER

K910925 · Cox Sterile Products, Inc. · General Hospital
May 1992
Decision
430d
Days
Class 2
Risk

About This 510(k) Submission

K910925 is an FDA 510(k) clearance for the DISINFECTION WITH THE COX DRY HEAT STERILIZER, a Sterilizer, Dry Heat (Class II — Special Controls, product code KMH), submitted by Cox Sterile Products, Inc. (Dallas, US). The FDA issued a Cleared decision on May 8, 1992, 430 days after receiving the submission on March 5, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6870.

Submission Details

510(k) Number K910925 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 1991
Decision Date May 08, 1992
Days to Decision 430 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KMH — Sterilizer, Dry Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6870

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