The following data is part of a premarket notification filed by Dymax Corp. with the FDA for Siterite Needle Guide (modified).
| Device ID | K931403 |
| 510k Number | K931403 |
| Device Name: | SITERITE NEEDLE GUIDE (MODIFIED) |
| Classification | Catheter, Percutaneous |
| Applicant | DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238 |
| Contact | Irene Skolnick |
| Correspondent | Irene Skolnick DYMAX CORP. 604 EPSILON DR. Pittsburgh, PA 15238 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-19 |
| Decision Date | 1993-07-27 |