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510(k) K973875

Device
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
Applicant
RESPIRONICS, INC.
510(k) number
K973875
Product code
KMA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-26
Date received
1997-10-10
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
FRANCIS X DOBSCHA
Address
1001 Murry Ridge Ln. Murrysville PA US 15668 15668

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
K140542NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANERRhinosystems, Inc.2014-06-27
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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