Device Classification Name |
bone cement
|
510(k) Number |
K050855 |
Device Name |
PALAMED G |
Applicant |
HERAEUS KULZER GMBH |
PHILLIP REIS-STRASSE 8/13 |
WEHRHEIM,
DE
D-61273
|
|
Applicant Contact |
CHRISTIAN TUCHSCHERER |
Correspondent |
HERAEUS KULZER GMBH |
PHILLIP REIS-STRASSE 8/13 |
WEHRHEIM,
DE
D-61273
|
|
Correspondent Contact |
CHRISTIAN TUCHSCHERER |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/04/2005 |
Decision Date | 07/07/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|