Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K042305 |
Device Name |
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 |
Applicant |
OSSACUR AG |
975 VERONICS SPRINGS ROAD |
SANTA BARBARA,
CA
93105
|
|
Applicant Contact |
KRISTI KISTNER |
Correspondent |
OSSACUR AG |
975 VERONICS SPRINGS ROAD |
SANTA BARBARA,
CA
93105
|
|
Correspondent Contact |
KRISTI KISTNER |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 08/25/2004 |
Decision Date | 10/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|