The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Dragonfly Surgical Drill System.
| Device ID | K161376 |
| 510k Number | K161376 |
| Device Name: | DragonFly Surgical Drill System |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Grace Medical, Inc. 8500 Wolf Lake Drive Suite 110 Memphis, TN 38133 |
| Contact | William Graham |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-05-18 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844505011075 | K161376 | 000 |
| 00844505010436 | K161376 | 000 |
| 00844505009874 | K161376 | 000 |
| 00844505009850 | K161376 | 000 |
| 00844505009768 | K161376 | 000 |
| 00844505009751 | K161376 | 000 |
| 00844505009744 | K161376 | 000 |
| 00844505009737 | K161376 | 000 |
| 00844505009713 | K161376 | 000 |