Device Classification Name |
Bone Cement
|
510(k) Number |
K031673 |
Device Name |
REFOBACIN -PALACOS G |
Applicant |
HERAEUS KULZER GMBH & CO. KG |
GRUNER WEG 11 |
HANAU,
DE
D-63450
|
|
Applicant Contact |
K.-D. KUHN |
Correspondent |
HERAEUS KULZER GMBH & CO. KG |
GRUNER WEG 11 |
HANAU,
DE
D-63450
|
|
Correspondent Contact |
K.-D. KUHN |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/30/2003 |
Decision Date | 05/25/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|