The following data is part of a premarket notification filed by Gyrus Acmi, Inc with the FDA for Diego Elite Drill.
| Device ID | K152744 |
| 510k Number | K152744 |
| Device Name: | DIEGO ELITE DRILL |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | GYRUS ACMI, INC 136 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Dolan Mills |
| Correspondent | Dolan Mills GYRUS ACMI, INC 136 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925035836 | K152744 | 000 |
| 00821925035805 | K152744 | 000 |
| 00821925035652 | K152744 | 000 |
| 00821925035645 | K152744 | 000 |
| 00821925035638 | K152744 | 000 |
| 00821925035621 | K152744 | 000 |
| 00821925035614 | K152744 | 000 |
| 00821925035607 | K152744 | 000 |