Device Classification Name |
Barrier, Animal Source, Intraoral
|
510(k) Number |
K121310 |
Device Name |
MESOTHELIUM DENTAL MEMBRANE |
Applicant |
KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE |
EXTON,
PA
19341
|
|
Applicant Contact |
LORI BURNS, MS, RAC |
Correspondent |
KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE |
EXTON,
PA
19341
|
|
Correspondent Contact |
LORI BURNS, MS, RAC |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 05/01/2012 |
Decision Date | 07/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|