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 |