The following data is part of a premarket notification filed by Scandimed. A.s. with the FDA for Varices Needle.
| Device ID | K031238 |
| 510k Number | K031238 |
| Device Name: | VARICES NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | SCANDIMED. A.S. 280 GODSHALL RD Collegeville, PA 19426 |
| Contact | Courtney Smith |
| Correspondent | Courtney Smith SCANDIMED. A.S. 280 GODSHALL RD Collegeville, PA 19426 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-18 |
| Decision Date | 2004-10-04 |