The following data is part of a premarket notification filed by Integra Lifesciences Corp. with the FDA for Neurogen Nerve Guide.
| Device ID | K011168 |
| 510k Number | K011168 |
| Device Name: | NEUROGEN NERVE GUIDE |
| Classification | Cuff, Nerve |
| Applicant | INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady INTEGRA LIFESCIENCES CORP. 105 MORGAN LANE 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 | 2001-04-17 |
| Decision Date | 2001-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780071860 | K011168 | 000 |
| 10381780026471 | K011168 | 000 |
| 10381780026488 | K011168 | 000 |
| 10381780026495 | K011168 | 000 |
| 10381780026501 | K011168 | 000 |
| 10381780026518 | K011168 | 000 |
| 10381780026525 | K011168 | 000 |
| 10381780026532 | K011168 | 000 |
| 10381780071822 | K011168 | 000 |
| 10381780071839 | K011168 | 000 |
| 10381780071846 | K011168 | 000 |
| 10381780071853 | K011168 | 000 |
| 10381780026464 | K011168 | 000 |