The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Codman Certas Plus Electronic Tool Kit.
| Device ID | K181902 |
| 510k Number | K181902 |
| Device Name: | Codman Certas Plus Electronic Tool Kit |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048 |
| Contact | Nancy Macdonald |
| Correspondent | Nancy Macdonald Integra LifeSciences Corp. 11 Cabot Blvd Mansfield, MA 02048 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2018-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780532897 | K181902 | 000 |