Device Classification Name |
barrier, synthetic, intraoral
|
510(k) Number |
K132325 |
Device Name |
GUIDOR BIORESORBABLE MATRIX BARRIER |
Applicant |
SUNSTAR AMERICAS, INC. |
575 8TH AVE, STE 1212 |
NEW YORK,
NY
10018
|
|
Applicant Contact |
DEBORAH L GRAYESKI |
Correspondent |
SUNSTAR AMERICAS, INC. |
575 8TH AVE, STE 1212 |
NEW YORK,
NY
10018
|
|
Correspondent Contact |
DEBORAH L GRAYESKI |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 07/26/2013 |
Decision Date | 10/29/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|