The following data is part of a premarket notification filed by Flexmedics with the FDA for Flexfinder Guidewire (regular Shaft/stiff Shaft) Marked Ink Bands Encap+/guidewire(regular Shaft/stiff Shaft) No Marking.
| Device ID | K964955 |
| 510k Number | K964955 |
| Device Name: | FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | FLEXMEDICS 12400 WHITEWATER DR. SUITE 2040 Minnetonka, MN 55343 |
| Contact | Pam L Schaub |
| Correspondent | Pam L Schaub FLEXMEDICS 12400 WHITEWATER DR. 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 | 1996-12-11 |
| Decision Date | 1997-02-14 |
| Summary: | summary |