Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K094061 |
Device Name |
KENSEY NASH ECM SURGICAL PATCH |
Applicant |
KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE |
EXTON,
PA
19341
|
|
Applicant Contact |
LORI A BURNS, MS, RAC |
Correspondent |
KENSEY NASH CORPORATION |
735 PENNSYLVANIA DRIVE |
EXTON,
PA
19341
|
|
Correspondent Contact |
LORI A BURNS, MS, RAC |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/31/2009 |
Decision Date | 05/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|