Device Classification Name |
Wax, Bone
|
510(k) Number |
K122156 |
Device Name |
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY |
Applicant |
ORTHOCON, INC. |
1 Bridge St Ste 121 |
Irvington,
NY
10533
|
|
Applicant Contact |
RICHARD KRONENTHAL |
Correspondent |
ORTHOCON, INC. |
1 Bridge St Ste 121 |
Irvington,
NY
10533
|
|
Correspondent Contact |
RICHARD KRONENTHAL |
Classification Product Code |
|
Date Received | 07/20/2012 |
Decision Date | 01/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|