The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Codman Disposable Perforators.
| Device ID | K183581 |
| 510k Number | K183581 |
| Device Name: | Codman Disposable Perforators |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048 |
| Contact | Jocelyn Raposo |
| Correspondent | Jocelyn Raposo Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-01-20 |
| Summary: | summary |