The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Liberator Beacon Tip Locking Stylet.
| Device ID | K170298 |
| 510k Number | K170298 |
| Device Name: | Liberator Beacon Tip Locking Stylet |
| Classification | Stylet, Catheter |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Steven Lawrie |
| Correspondent | Steven Lawrie Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-31 |
| Decision Date | 2017-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002200067 | K170298 | 000 |