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510(k) K800442

Device
VARIOTHERM
Applicant
JEDMED INSTRUMENT CO.
510(k) number
K800442
Product code
ETP  
Decision
Substantially Equivalent (SESE)
Decision date
1980-03-10
Date received
1980-02-28
Regulation
874.1800
Classification name
Stimulator, Caloric-water
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ETP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863615ENTHERMO IRRIGATION UNITJedmed Instrument Co.1986-12-16
K820775VESTIBULARISETJedmed Instrument Co.1982-11-03
K821481NASAL-THROAT SPRAY IRRIGATION INSTRUM.Ethicare Products1982-06-14
K813552MODEL 3000C CALORIC IRRIGATORLife-Tech Intl., Inc.1982-02-22
K800443HYGROTHERMJedmed Instrument Co.1980-03-10

Legacy Summary#

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FDA Review#

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