The following data is part of a premarket notification filed by Neoligaments, Ltd. with the FDA for Reamer Bit.
| Device ID | K930339 |
| 510k Number | K930339 |
| Device Name: | REAMER BIT |
| Classification | Bit, Drill |
| Applicant | NEOLIGAMENTS, LTD. 28-30 BLENHEIM TERRACE Leeds, GB Ls2-9hd |
| Contact | Rowland |
| Correspondent | Rowland NEOLIGAMENTS, LTD. 28-30 BLENHEIM TERRACE Leeds, GB Ls2-9hd |
| Product Code | HTW |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-25 |
| Decision Date | 1993-08-06 |