Device Classification Name |
bone cement
|
510(k) Number |
K014199 |
Device Name |
SURGICAL SIMPLEX P WITH TOBRAMYCIN |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
WILLIAM J CYMBALUK |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
WILLIAM J CYMBALUK |
Regulation Number | 888.3027
|
Classification Product Code |
|
Date Received | 12/21/2001 |
Decision Date | 05/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|