| Device Classification Name |
Tissue Expander And Accessories
|
| 510(k) Number |
K864185 |
| Device Name |
MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN |
| Applicant |
| Mcghan Medical Corp. |
| 700 Ward Dr. |
|
Santa Barbara,
CA
93111
|
|
| Applicant Contact |
LAURENS LICHTY |
| Correspondent |
| Mcghan Medical Corp. |
| 700 Ward Dr. |
|
Santa Barbara,
CA
93111
|
|
| Correspondent Contact |
LAURENS LICHTY |
| Classification Product Code |
|
| Date Received | 10/27/1986 |
| Decision Date | 12/24/1986 |
| 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
|