The following data is part of a premarket notification filed by Ximed/prosure/injectx with the FDA for Injection Needle Probe/device-tunis.
| Device ID | K983765 |
| 510k Number | K983765 |
| Device Name: | INJECTION NEEDLE PROBE/DEVICE-TUNIS |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-26 |
| Decision Date | 1998-12-11 |