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510(k) K851307

Device
INOX DRY HEAT STERILIZER
Applicant
BROADWEST CORP.
510(k) number
K851307
Product code
KMH  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-09
Date received
1985-04-01
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
JACK DONOVAN
Address
260 W. Broadway New York NY US 10013 10013

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
K881371COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLECox Sterile Products, Inc.1988-04-13
K872643COX RAPID HEAT TRANSFER STERILIZERCox Sterile Products, Inc.1987-10-29
K871615U. V. GERMICIDAL UNITLorvic Corp.1987-09-11
K771070DRY HEAT STERILIZERCpac, Inc.1977-07-14

Legacy Summary#

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FDA Review#

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