Device Classification Name |
Drills, Burrs, Trephines & Accessories (Simple, Powered)
|
510(k) Number |
K183545 |
Device Name |
Anspach Helix Dissection Tools |
Applicant |
The Anspach Effort, Inc. |
4500 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Applicant Contact |
Tamara J. West |
Correspondent |
The Anspach Effort, Inc. |
4500 Riverside Drive |
Palm Beach Gardens,
FL
33410
|
|
Correspondent Contact |
Tamara J. West |
Regulation Number | 882.4310
|
Classification Product Code |
|
Date Received | 12/20/2018 |
Decision Date | 07/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|