The following data is part of a premarket notification filed by Flex Medics Corporation with the FDA for Flex Finder Guidewire.
Device ID | K923755 |
510k Number | K923755 |
Device Name: | FLEX FINDER GUIDEWIRE |
Classification | Endoscopic Guidewire, Gastroenterology-urology |
Applicant | Flex Medics Corporation 12400 Whitewater Drive, Suite 2040 Minnetonka, MN 55343 |
Contact | Daniel Corcoran |
Correspondent | Debra K. Fritz Flex Medics Corporation 12400 Whitewater Drive, Suite 2040 Minnetonka, MN 55343 |
Product Code | OCY |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-24 |
Decision Date | 1993-09-03 |