The following data is part of a premarket notification filed by Lone Star Technologies with the FDA for Flare,file, Fill.
| Device ID | K981234 |
| 510k Number | K981234 |
| Device Name: | FLARE,FILE, FILL |
| Classification | Handle, Instrument, Dental |
| Applicant | LONE STAR TECHNOLOGIES 31 RUNNYMEADE Chatham, NJ 07928 |
| Contact | Edward Spehar |
| Correspondent | Edward Spehar LONE STAR TECHNOLOGIES 31 RUNNYMEADE Chatham, NJ 07928 |
| Product Code | EJB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-04 |
| Decision Date | 1998-06-05 |