Device Classification Name |
Bone Grafting Material, Animal Source
|
510(k) Number |
K142040 |
Device Name |
OCS-B COLLAGEN |
Applicant |
NIBEC CO LTD |
904 E. WINDSOR ROAD #102 |
GLENDALE,
CA
91203
|
|
Applicant Contact |
DANIEL NAM |
Correspondent |
NIBEC CO LTD |
904 E. WINDSOR ROAD #102 |
GLENDALE,
CA
91203
|
|
Correspondent Contact |
DANIEL NAM |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 07/28/2014 |
Decision Date | 07/31/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|