The following data is part of a premarket notification filed by Dambrecine, Inc. with the FDA for Spine Line.
| Device ID | K922366 |
| 510k Number | K922366 |
| Device Name: | SPINE LINE |
| Classification | Massager, Therapeutic, Manual |
| Applicant | DAMBRECINE, INC. 10151 UNIVERSITY BLVD., SUITE 237 Orlando, FL 32817 |
| Contact | Michael Dambro |
| Correspondent | Michael Dambro DAMBRECINE, INC. 10151 UNIVERSITY BLVD., SUITE 237 Orlando, FL 32817 |
| Product Code | LYG |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1992-07-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPINE LINE 75941419 2718384 Dead/Cancelled |
Tutogen Medical GmbH 2000-03-10 |