510(k) K881371

Device
COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE
Applicant
COX STERILE PRODUCTS, INC.
510(k) number
K881371
Product code
KMH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-13
Date received
1988-04-01
Regulation
880.6870
Classification name
Sterilizer, Dry Heat
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
COX, D.D.S.
Address
5115 Mckinney Ave., Suite C Dallas TX US 75205 75205

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K094026STERI-DENT, STERI-SURECpac, Inc.2011-07-12
K051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMColtene/Whaledent, Inc.2005-08-04
K910925DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.1992-05-08
K910202DENTRONIX MODEL 2000Dentronix, Inc.1991-03-13
K880322DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEMDentronix, Inc.1988-07-13
K872643COX RAPID HEAT TRANSFER STERILIZERCox Sterile Products, Inc.1987-10-29
K871615U. V. GERMICIDAL UNITLorvic Corp.1987-09-11
K851307INOX DRY HEAT STERILIZERBroadwest Corp.1985-05-09
K771070DRY HEAT STERILIZERCpac, Inc.1977-07-14

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases