The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexfinder Guide Wire(regular Shaft/stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (regular Shaft/stiff Shaft) No.
| Device ID | K990765 |
| 510k Number | K990765 |
| Device Name: | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Contact | William C Corrigan, Jr. |
| Correspondent | William C Corrigan, Jr. FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-08 |
| Decision Date | 1999-03-15 |