The following data is part of a premarket notification filed by Spinemedica, Llc with the FDA for Paradis Vaso Shield.
| Device ID | K093551 |
| 510k Number | K093551 |
| Device Name: | PARADIS VASO SHIELD |
| Classification | Vessel Guard Or Cover |
| Applicant | SPINEMEDICA, LLC 811 LIVINGSTON COURT SUITE B Marietta, GA 30067 |
| Contact | Sally Thorsen |
| Correspondent | Sally Thorsen SPINEMEDICA, LLC 811 LIVINGSTON COURT SUITE B Marietta, GA 30067 |
| Product Code | OMR |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2009-12-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PARADIS VASO SHIELD 77580938 3842201 Dead/Cancelled |
MIMEDX PROCESSING SERVICES, LLC 2008-09-29 |