The following data is part of a premarket notification filed by Cook Ireland Ltd with the FDA for Injekt Cysto Flexible Injection Needle.
| Device ID | K113634 |
| 510k Number | K113634 |
| Device Name: | INJEKT CYSTO FLEXIBLE INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE El |
| Contact | Laura Guinane |
| Correspondent | Laura Guinane COOK IRELAND LTD O'HALLORAN ROAD NATIONAL TECHNOLOGY PARK Limerick, IE El |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-09 |
| Decision Date | 2012-02-14 |
| Summary: | summary |