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 |