Device Classification Name |
wax, bone
|
510(k) Number |
K142339 |
Device Name |
HEMASORB Resorbable Hemostatic Bone Putty |
Applicant |
ORTHOCON, LLC |
1 Bridge Street -Suite 121 |
Irvington,
NY
10533
|
|
Applicant Contact |
Howard L Schrayer |
Correspondent |
ORTHOCON, LLC |
1 Bridge Street -Suite 121 |
Irvington,
NY
10533
|
|
Correspondent Contact |
Howard L Schrayer |
Classification Product Code |
|
Date Received | 08/21/2014 |
Decision Date | 09/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|