NEURAGEN 3D
Cuff, Nerve
INTEGRA LIFESCIENCES CORPORATION
The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Neuragen 3d.
Pre-market Notification Details
| Device ID | K130557 |
| 510k Number | K130557 |
| Device Name: | NEURAGEN 3D |
| Classification | Cuff, Nerve |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Stephen H Beier |
| Correspondent | Stephen H Beier INTEGRA LIFESCIENCES CORPORATION 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 | Yes |
| Date Received | 2013-03-04 |
| Decision Date | 2014-04-24 |
| Summary: | summary |
Trademark Results [NEURAGEN 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEURAGEN 3D 88863926 not registered Live/Pending |
Integra LifeSciences Corporation 2020-04-08 |
 NEURAGEN 3D 87195169 not registered Live/Pending |
Integra LifeSciences Corporation 2016-10-06 |
 NEURAGEN 3D 85875225 not registered Dead/Abandoned |
Integra LifeSciences Corporation 2013-03-13 |
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