ENLUXTRA HUMIFIBER WOUND DRESSING


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

Correspodent Contact nadi ergenc, ph.d.
Classification Product Code
FRO  
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