Device Classification Name |
bandage, liquid
|
510(k) Number |
K083087 |
Device Name |
ECOCEL |
Applicant |
POLICHEM S.A. |
7361 CALHOUN PLACE |
SUITE 500 |
ROCKVILLE,
MD
20855
|
|
Applicant Contact |
HARI NAGARADONA |
Correspondent |
POLICHEM S.A. |
7361 CALHOUN PLACE |
SUITE 500 |
ROCKVILLE,
MD
20855
|
|
Correspondent Contact |
HARI NAGARADONA |
Regulation Number | 880.5090
|
Classification Product Code |
|
Date Received | 10/16/2008 |
Decision Date | 08/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|