Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K122297 |
Device Name |
ENLUXTRA HUMIFIBER WOUND DRESSING |
Applicant |
BASF VENTURE CAPITAL AMERICA INC. |
100 CAMPUS DRIVE |
FLORAM PARK,
NJ
07932
|
|
Applicant Contact |
NADI ERGENC, PH.D. |
Correspondent |
BASF VENTURE CAPITAL AMERICA INC. |
100 CAMPUS DRIVE |
FLORAM PARK,
NJ
07932
|
|
Correspondent Contact |
NADI ERGENC, PH.D. |
Classification Product Code |
|
Date Received | 07/31/2012 |
Decision Date | 08/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|