Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K042340 |
Device Name |
KASIOS TCP |
Applicant |
KASIOS BIOMATERIALS |
45900 PARSIPPANY COURT |
TEMECULA,
CA
92592
|
|
Applicant Contact |
LAETITA BERNARD |
Correspondent |
KASIOS BIOMATERIALS |
45900 PARSIPPANY COURT |
TEMECULA,
CA
92592
|
|
Correspondent Contact |
LAETITA BERNARD |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 08/30/2004 |
Decision Date | 11/24/2004 |
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
|
|
|