Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K050657 |
Device Name |
MONDEAL CONTOUR HO SYSTEM |
Applicant |
KAPP SURGICAL INSTRUMENT, INC. |
4919 WARRENSVILLE CENTER RD. |
CLEVELAND,
OH
44128
|
|
Applicant Contact |
ALBERT SANTILLI |
Correspondent |
KAPP SURGICAL INSTRUMENT, INC. |
4919 WARRENSVILLE CENTER RD. |
CLEVELAND,
OH
44128
|
|
Correspondent Contact |
ALBERT SANTILLI |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 03/14/2005 |
Decision Date | 08/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|