Cleared Traditional

K872643 - COX RAPID HEAT TRANSFER STERILIZER
(FDA 510(k) Clearance)

K872643 · Cox Sterile Products, Inc. · General Hospital

Oct 1987

Decision

115d

Days

Class 2

Risk

K872643 is an FDA 510(k) clearance for the COX RAPID HEAT TRANSFER STERILIZER. This device is classified as 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 October 29, 1987, 115 days after receiving the submission on July 6, 1987.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6870.

Submission Details

510(k) Number	K872643 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 1987
Decision Date	October 29, 1987
Days to Decision	115 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—