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510(k) K140542

Device
NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
Applicant
RHINOSYSTEMS, INC.
510(k) number
K140542
Product code
KMA  
Decision
Substantially Equivalent (SESE)
Decision date
2014-06-27
Date received
2014-03-04
Regulation
874.5550
Classification name
Irrigator, Powered Nasal
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTIN R HOKE
Address
5399 Lancaster Dr. # 6 Brooklyn Heights OH US 44131 44131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K822351POWDER BLOWERSKelleher Corp.1982-09-14

Legacy Summary#

summary

FDA Review#

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