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510(k) K970994

Device
CORE AND COIL ASSEMBLY GUIDEWIRE
Applicant
LAKE REGION MFG., INC.
510(k) number
K970994
Product code
EZB  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-25
Date received
1997-03-19
Regulation
876.5130
Classification name
Stylet For Catheter, Gastro-urology
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
KIM AVES
Address
340 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K874164GUIDE WIREEndovations1987-12-07

Legacy Summary#

summary

FDA Review#

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