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510(k) K093718

Device
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
Applicant
ZUTRON MEDICAL LLC
510(k) number
K093718
Product code
FCY  
Decision
Substantially Equivalent (SESE)
Decision date
2010-02-22
Date received
2009-12-02
Regulation
876.1500
Classification name
Bulb, Inflation, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JORDAN HARTONG
Address
9816 Pflumm Rd. Lenexa KS US 66215 66215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904376ANEROID BLOOD PRESSURE GAUGEBiomedical Dynamics, Inc.1990-12-20
K900016TRANS/R - FP(3)CIVCO Medical Instruments Co., Inc.1990-06-11

Legacy Summary#

summary

FDA Review#

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