Device Classification Name |
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
|
510(k) Number |
K052735 |
Device Name |
ALLOCRAFT DBM |
Applicant |
LIFECELL CORP. |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSTEIN |
Correspondent |
LIFECELL CORP. |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSTEIN |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2005 |
Decision Date | 12/28/2005 |
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
|
|
|