Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K103568 |
Device Name |
RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
JANELL A COLLEY |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
JANELL A COLLEY |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/06/2010 |
Decision Date | 12/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|