Device Classification Name |
Drills, Burrs, Trephines & Accessories (Simple, Powered)
|
510(k) Number |
K113476 |
Device Name |
ANSPACH DISSECTION TOOLS |
Applicant |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR. |
Palm Bch Gdns,
FL
33410
|
|
Applicant Contact |
JEANNETTE G DAILEY |
Correspondent |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR. |
Palm Bch Gdns,
FL
33410
|
|
Correspondent Contact |
JEANNETTE G DAILEY |
Regulation Number | 882.4310
|
Classification Product Code |
|
Date Received | 11/22/2011 |
Decision Date | 12/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|