The following data is part of a premarket notification filed by Eupalamus, Llc. with the FDA for Eupalamus Deflectable Stylet, Model 01545.
| Device ID | K002534 |
| 510k Number | K002534 |
| Device Name: | EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 |
| Classification | Stylet, Catheter |
| Applicant | EUPALAMUS, LLC. 3411 MANDEVILLE CANYON RD. Brentwood, CA 90049 |
| Contact | Anne Lauritzen |
| Correspondent | Anne Lauritzen EUPALAMUS, LLC. 3411 MANDEVILLE CANYON RD. Brentwood, CA 90049 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-16 |
| Decision Date | 2000-10-18 |