The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Neura Wrap Nerve Protector.
| Device ID | K041620 |
| 510k Number | K041620 |
| Device Name: | NEURA WRAP NERVE PROTECTOR |
| Classification | Cuff, Nerve |
| Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Diana M Bordon |
| Correspondent | Diana M Bordon INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-16 |
| Decision Date | 2004-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780071815 | K041620 | 000 |
| 10381780071808 | K041620 | 000 |
| 10381780026457 | K041620 | 000 |
| 10381780026440 | K041620 | 000 |
| 10381780026433 | K041620 | 000 |
| 10381780026426 | K041620 | 000 |
| 10381780026419 | K041620 | 000 |
| 10381780026402 | K041620 | 000 |