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510(k) K953465

Device
KENTEMP
Applicant
KENTRON HEALTH CARE, INC.
510(k) number
K953465
Product code
FLK  
Decision
Substantially Equivalent (SESE)
Decision date
1995-12-15
Date received
1995-07-24
Regulation
880.2920
Classification name
Thermometer, Clinical Mercury
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NARI SADARANGANI
Address
4330 Sheridan St. Hollywood FL US 33021 33021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FLK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.1996-03-28
K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.1996-03-25
K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.1995-03-28
K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.1994-08-25
K940394AMG MED BRAND CLINICAL GLASS THERMOMETERTechnolab Industries (Canada) , Ltd.1994-05-04
K940380AMG MED BRAND CLINICAL GLASS THERMOMETERAmg Medical, Inc.1994-05-04
K932991GUARDIAN AND ANDINO MODELSColtemp, Inc.1994-01-28
K923225LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOMELorrex Health Products1993-06-08
K913793SIMPEX INC. ORAL AND RECTAL THERMOMETERSSimpex, Inc.1991-12-30
K911269MERCURY AND GLASS FEVER THERMOMETERSteridyne Corp.1991-05-15
K902625CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPITLiaoning-Usa Corp.1990-10-26
K903500MASCOT THERMOTERMascot, Inc.1990-10-09
K901790THERMOMETER, MERCURY/CLINICALPerlink USA, Inc.1990-07-11
K900646MERCURY THERMOMETERS (ORAL AND RECTAL)Abel Industries, Inc.1990-07-11
K897054CLINICAL MERCURY THERMOMETERCypress Medical Products, Ltd.1990-03-22

Legacy Summary#

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FDA Review#

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