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510(k) K822179

Device
FRENZEL EYEGLASSES & RELATED ITEMS
Applicant
KELLEHER CORP.
510(k) number
K822179
Product code
KHH  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-21
Date received
1982-07-23
Regulation
874.1800
Classification name
Stimulator, Caloric-air
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 KHH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950785HORTMANN AIRMATIC AIR CALORIC STIMULATORJedmed Instrument Co.1995-06-28
K946108EAR-A-GATORLife-Tech Intl., Inc.1995-06-13
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

Legacy Summary#

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FDA Review#

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