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510(k) K822351

Device
POWDER BLOWERS
Applicant
KELLEHER CORP.
510(k) number
K822351
Product code
KMA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-09-14
Date received
1982-08-06
Regulation
874.5550
Classification name
Irrigator, Powered Nasal
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 KMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140542NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANERRhinosystems, Inc.2014-06-27
K973875RINOFLOW MICRONIZED E.N.T. WASH SYSTEMRespironics, Inc.1998-01-26
K963550RINOFLOW MICRONIZED E.N..T. WASH SYTSTEMRespironics, Inc.1996-11-01
K950078MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.1995-06-21

Legacy Summary#

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FDA Review#

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