| 510(k) Number |
K910072 |
| Device Name |
SURE GRIP, HAND CONTROLS MODEL SG-1 |
| Applicant |
| Howell Ventures , Ltd. |
| Rr #6 |
|
Fredericton, N.B.,
CA
E3B 4X7
|
|
| Applicant Contact |
KEITH HOWELL |
| Correspondent |
| Howell Ventures , Ltd. |
| Rr #6 |
|
Fredericton, N.B.,
CA
E3B 4X7
|
|
| Correspondent Contact |
KEITH HOWELL |
| Classification Product Code |
|
| Date Received | 01/09/1991 |
| Decision Date | 01/23/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|