| Device Classification Name |
Motor, Drill, Pneumatic
|
| 510(k) Number |
K962483 |
| Device Name |
MIDAS REX III MOTOR |
| Applicant |
| Midas Rex Pneumatic Tools, Inc. |
| 3001 Race St. |
|
Fort Worth,
TX
76111
|
|
| Applicant Contact |
MICHAEL FOWLER |
| Correspondent |
| Midas Rex Pneumatic Tools, Inc. |
| 3001 Race St. |
|
Fort Worth,
TX
76111
|
|
| Correspondent Contact |
MICHAEL FOWLER |
| Regulation Number | 882.4370 |
| Classification Product Code |
|
| Date Received | 06/26/1996 |
| Decision Date | 11/19/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|