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510(k) K813552

Device
MODEL 3000C CALORIC IRRIGATOR
Applicant
LIFE-TECH INTL., INC.
510(k) number
K813552
Product code
ETP  
Decision
Substantially Equivalent (SESE)
Decision date
1982-02-22
Date received
1981-12-21
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K800442VARIOTHERMJedmed Instrument Co.1980-03-10
K800443HYGROTHERMJedmed Instrument Co.1980-03-10

Legacy Summary#

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FDA Review#

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