Device Classification Name |
bone grafting material, human source
|
510(k) Number |
K130235 |
Device Name |
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY |
Applicant |
HANS BIOMED CORP. |
5600 WISCONSIN AVENUE #509 |
CHEVY CHASE,
MD
20815
|
|
Applicant Contact |
PATSY J TRISLER, JD, RAC |
Correspondent |
HANS BIOMED CORP. |
5600 WISCONSIN AVENUE #509 |
CHEVY CHASE,
MD
20815
|
|
Correspondent Contact |
PATSY J TRISLER, JD, RAC |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 01/30/2013 |
Decision Date | 01/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|