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510(k) K946108

Device
EAR-A-GATOR
Applicant
LIFE-TECH INTL., INC.
510(k) number
K946108
Product code
KHH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-13
Date received
1994-12-14
Regulation
874.1800
Classification name
Stimulator, Caloric-air
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALFRED C COATS
Address
P.O. Box 36221 Houston TX US 77236 77236

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KHH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950785HORTMANN AIRMATIC AIR CALORIC STIMULATORJedmed Instrument Co.1995-06-28
K941325WATER IRRIGATOR, W1 200Strong Medical, Inc.1994-08-09
K931608NCA-200Ics Medical Corp.1993-06-22
K925237AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.1993-05-05
K881630AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.1988-06-21
K822179FRENZEL EYEGLASSES & RELATED ITEMSKelleher Corp.1982-09-21

Legacy Summary#

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FDA Review#

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