| Device Classification Name |
Tissue Expander And Accessories
|
| 510(k) Number |
K845036 |
| FOIA Releasable 510(k) |
K845036
|
| Device Name |
TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 |
| Applicant |
| Progress Mankind Technology |
| Box 464 |
|
Hopkins,
MN
55343
|
|
| Applicant Contact |
ALFRED A IVERSEN |
| Correspondent |
| Progress Mankind Technology |
| Box 464 |
|
Hopkins,
MN
55343
|
|
| Correspondent Contact |
ALFRED A IVERSEN |
| Classification Product Code |
|
| Date Received | 12/27/1984 |
| Decision Date | 06/26/1985 |
| 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
|