The following data is part of a premarket notification filed by Ximed/prosure/injectx with the FDA for Injection/aspiration Needles Probes/devices-tpi/tpi Flex.
| Device ID | K983200 |
| 510k Number | K983200 |
| Device Name: | INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX |
| Classification | Needle, Aspiration And Injection, Disposable |
| 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 | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1998-12-11 |