Device Classification Name |
Motor, Drill, Pneumatic
|
510(k) Number |
K061297 |
Device Name |
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM |
Applicant |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Applicant Contact |
JAMES CARBONE |
Correspondent |
THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR. |
PALM BEACH GARDENS,
FL
33410
|
|
Correspondent Contact |
JAMES CARBONE |
Regulation Number | 882.4370
|
Classification Product Code |
|
Date Received | 05/09/2006 |
Decision Date | 01/26/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|