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510(k) K131177

Device
SINUFLUSH LAVAGE SYSTEM
Applicant
HEDGEPATH, LLC
510(k) number
K131177
Product code
KAR  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-20
Date received
2013-04-25
Regulation
874.4420
Classification name
Irrigator, Sinus
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
FRANK E O'DONNELL, JR MD.
Address
324 S. Hyde Park Ave. Suite 350 Tampa FL US 33606 33606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931398GM SWIVEL VIDEO (TM) IRRIGATORGm Engineering, Inc.1993-08-30
K861298FISCH DRILL IRRIGATORJedmed Instrument Co.1986-04-23

Legacy Summary#

summary

FDA Review#

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