Device Classification Name |
Bone Cement
|
510(k) Number |
K041656 |
Device Name |
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
TIFFANI ROGERS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
TIFFANI ROGERS |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/18/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|