Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K101587 |
Device Name |
PROPATCH SOFT TISSUE REPAIR MATRIX |
Applicant |
CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. |
KENNESAW,
GA
30144
|
|
Applicant Contact |
BRYAN BROSSEAU |
Correspondent |
CRYOLIFE, INC. |
1655 ROBERTS BLVD., N.W. |
KENNESAW,
GA
30144
|
|
Correspondent Contact |
BRYAN BROSSEAU |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2010 |
Decision Date | 09/16/2010 |
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
|
|
|