| Device Classification Name |
Transducer, Ultrasonic, Diagnostic
|
| 510(k) Number |
K963302 |
| Device Name |
TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM |
| Applicant |
| Tayman Medical, Inc. |
| 15 Foxhunt Dr. |
|
Chesterfield,
MO
63017
|
|
| Applicant Contact |
JAMES TAYLOR |
| Correspondent |
| Tayman Medical, Inc. |
| 15 Foxhunt Dr. |
|
Chesterfield,
MO
63017
|
|
| Correspondent Contact |
JAMES TAYLOR |
| Regulation Number | 892.1570 |
| Classification Product Code |
|
| Date Received | 08/22/1996 |
| Decision Date | 02/06/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|