The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Injekt Filiform Injection Needle.
| Device ID | K082319 |
| 510k Number | K082319 |
| Device Name: | INJEKT FILIFORM INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Contact | Cindy Foote |
| Correspondent | Cindy Foote COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-09-25 |
| Summary: | summary |