The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Mayfield Mr/x-ray Skull Clamp.
| Device ID | K081401 |
| 510k Number | K081401 |
| Device Name: | MAYFIELD MR/X-RAY SKULL CLAMP |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2008-10-08 |
| Summary: | summary |