Device Classification Name |
cement, bone, vertebroplasty
|
510(k) Number |
K062424 |
Device Name |
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT |
Applicant |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 888.3027
|
Classification Product Code |
|
Date Received | 08/18/2006 |
Decision Date | 09/14/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|