Device Classification Name |
Tracking, Soft Tissue, Intraoperative
|
510(k) Number |
K071063 |
Device Name |
LINASYS |
Applicant |
PATHFINDER THERAPEUTICS, INC. |
2969 ARMORY DRIVE |
SUITE 100A |
NASHVILLE,
TN
37204
|
|
Applicant Contact |
JAMES D STEFANSIC |
Correspondent |
PATHFINDER THERAPEUTICS, INC. |
2969 ARMORY DRIVE |
SUITE 100A |
NASHVILLE,
TN
37204
|
|
Correspondent Contact |
JAMES D STEFANSIC |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 04/16/2007 |
Decision Date | 12/20/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|