| 510(k) Number |
K844157 |
| Device Name |
HOLDSTER ARM RETENTION SYSTEM |
| Applicant |
| P.G.L. Medical |
| 277 Edgewood Ave. |
|
San Francisco,
CA
94117
|
|
| Applicant Contact |
PETER B FOX |
| Correspondent |
| P.G.L. Medical |
| 277 Edgewood Ave. |
|
San Francisco,
CA
94117
|
|
| Correspondent Contact |
PETER B FOX |
| Date Received | 10/24/1984 |
| Decision Date | 01/23/1985 |
| 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
|
|
|