Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K053424 |
Device Name |
POPMESH |
Applicant |
CALDERA MEDICAL, INC. |
28632 ROADSIDE DR., SUITE 260 |
AGOURA HILLS,
CA
91301
|
|
Applicant Contact |
MARLA KENGEN |
Correspondent |
CALDERA MEDICAL, INC. |
28632 ROADSIDE DR., SUITE 260 |
AGOURA HILLS,
CA
91301
|
|
Correspondent Contact |
MARLA KENGEN |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 12/08/2005 |
Decision Date | 02/22/2006 |
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
|
|
|