| Device Classification Name |
Blood Pressure Cuff
|
| 510(k) Number |
K953466 |
| Device Name |
GENERICUFF |
| Applicant |
| Generic Medical, Inc. |
| 2880 Holcomb Bridge Rd. |
| # B-9 1124 |
|
Alpharetta,
GA
30004
|
|
| Applicant Contact |
DAVID L WALSH |
| Correspondent |
| Generic Medical, Inc. |
| 2880 Holcomb Bridge Rd. |
| # B-9 1124 |
|
Alpharetta,
GA
30004
|
|
| Correspondent Contact |
DAVID L WALSH |
| Regulation Number | 870.1120 |
| Classification Product Code |
|
| Date Received | 07/24/1995 |
| Decision Date | 09/15/1995 |
| 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
|
|
|