| 510(k) Number |
K844462 |
| Device Name |
DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER |
| Applicant |
| Washington-Greene County Branch Pennsylvania Assoc |
| 566 E. Maiden St. |
|
Washington,
PA
15301
|
|
| Applicant Contact |
DENNIS R CHARLTON |
| Correspondent |
| Washington-Greene County Branch Pennsylvania Assoc |
| 566 E. Maiden St. |
|
Washington,
PA
15301
|
|
| Correspondent Contact |
DENNIS R CHARLTON |
| Date Received | 11/15/1984 |
| Decision Date | 12/12/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|