FDA.reportPublic FDA data

510(k) K963550

Device
Rinoflow Micronized E.n..t. Wash Sytstem
Applicant
RESPIRONICS, INC.
510(k) number
K963550
Product code
KMA
Decision
Substantially Equivalent (SESE)
Decision date
1996-11-01
Date received
1996-09-05
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
FRAMCIS 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
K973875RINOFLOW MICRONIZED E.N.T. WASH SYSTEMRespironics, Inc.1998-01-26
K950078MICROFLOW IRRIGATION SYSTEMJedmed Instrument Co.1995-06-21
K822351POWDER BLOWERSKelleher Corp.1982-09-14