The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Modification To: Mayfield Radiolucent Skull Pins, Model 4-0-a-2020.
Device ID | K053045 |
510k Number | K053045 |
Device Name: | MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 |
Classification | Holder, Head, Neurosurgical (skull Clamp) |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
Contact | Donna Wallace |
Correspondent | Donna Wallace INTEGRA LIFESCIENCES CORPORATION 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 | 2005-10-28 |
Decision Date | 2005-11-21 |
Summary: | summary |