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510(k) K874164

Device
GUIDE WIRE
Applicant
ENDOVATIONS
510(k) number
K874164
Product code
EZB  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-07
Date received
1987-10-13
Regulation
876.5130
Classification name
Stylet For Catheter, Gastro-urology
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUSAN P BJORKMAN
Address
895 Poplar Church Rd. Camp Hill PA US 17011 17011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EZB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971498APPLIED MEDICAL LAPAROSCOPIC GUIDEWIREApplied Medical Resources1997-05-05
K970994CORE AND COIL ASSEMBLY GUIDEWIRELake Region Mfg., Inc.1997-03-25

Legacy Summary#

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FDA Review#

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