Device Classification Name |
wax, bone
|
510(k) Number |
K113079 |
Device Name |
SYNTHES HEMOSTATIC BONE PUTTY |
Applicant |
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION |
1230 Wilson Dr |
West Chester,
PA
19380
|
|
Applicant Contact |
JEFFREY L DOW |
Correspondent |
SYNTHES (USA) PRODUCTS LLC/NORIAN CORPORATION |
1230 Wilson Dr |
West Chester,
PA
19380
|
|
Correspondent Contact |
JEFFREY L DOW |
Classification Product Code |
|
Date Received | 10/17/2011 |
Decision Date | 12/13/2011 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|