| Device Classification Name |
Blood Pressure Cuff
|
| 510(k) Number |
K931087 |
| Device Name |
CLEANCUFF(TM) |
| Applicant |
| Med-Con, Inc. |
| 7625 E. Lamar Alexander Pkwy. |
| P.O. Box 490 |
|
Townsend,
TN
37882
|
|
| Applicant Contact |
CLAY WILSON |
| Correspondent |
| Med-Con, Inc. |
| 7625 E. Lamar Alexander Pkwy. |
| P.O. Box 490 |
|
Townsend,
TN
37882
|
|
| Correspondent Contact |
CLAY WILSON |
| Regulation Number | 870.1120 |
| Classification Product Code |
|
| Date Received | 03/03/1993 |
| Decision Date | 05/27/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|