Device Classification Name |
prosthesis, breast, external, used with adhesive
|
510(k) Number |
K951324 |
Device Name |
MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS |
Applicant |
MAXOL LIMITED L.C. |
10006 WEST 97 TERRACE |
OVERLAND PARK,
KS
66212
|
|
Applicant Contact |
MARK SCHANZE |
Correspondent |
MAXOL LIMITED L.C. |
10006 WEST 97 TERRACE |
OVERLAND PARK,
KS
66212
|
|
Correspondent Contact |
MARK SCHANZE |
Regulation Number | 878.3800
|
Classification Product Code |
|
Date Received | 03/23/1995 |
Decision Date | 05/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|