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510(k) K931398

Device
GM SWIVEL VIDEO (TM) IRRIGATOR
Applicant
GM ENGINEERING, INC.
510(k) number
K931398
Product code
KAR  
Decision
Substantially Equivalent (SESE)
Decision date
1993-08-30
Date received
1993-03-19
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
DAVID STEFFIN
Address
2549 Sierra Way, Suite B La Verne CA US 91750 91750

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KAR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K131177SINUFLUSH LAVAGE SYSTEMHedgepath, LLC2013-09-20
K861298FISCH DRILL IRRIGATORJedmed Instrument Co.1986-04-23

Legacy Summary#

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FDA Review#

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