The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Cook Brach Needle/radio Deliv Cath/flexi Flexicath.
| Device ID | K940550 |
| 510k Number | K940550 |
| Device Name: | COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | COOK, INC. 925 SOUTH CURRY PK Bloomington, IN 47403 -2624 |
| Contact | April Lavender |
| Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PK Bloomington, IN 47403 -2624 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-08-17 |