The following data is part of a premarket notification filed by Renovo Life Llc with the FDA for Renovo Life Hard Carbon Coated Drill Bit.
| Device ID | K151661 |
| 510k Number | K151661 |
| Device Name: | Renovo Life Hard Carbon Coated Drill Bit |
| Classification | Bit, Drill |
| Applicant | Renovo Life LLC 1104 Spruce Street Belmont, NC 28012 |
| Contact | Harold Crowder |
| Correspondent | Donald W Gunther Orgenix LLC 111 Hill Road Douglassville, PA 19518 |
| Product Code | HTW |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-19 |
| Decision Date | 2016-01-15 |
| Summary: | summary |