The following data is part of a premarket notification filed by Micromed Development Corp. with the FDA for Edi-bur Microdrill Systems.
| Device ID | K945438 |
| 510k Number | K945438 |
| Device Name: | EDI-BUR MICRODRILL SYSTEMS |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Contact | Dan H Treace |
| Correspondent | Dan H Treace MICROMED DEVELOPMENT CORP. 4911 CREEKSIDE DR. Clearwater, FL 34620 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1994-11-22 |