510(k) K083087

ECOCEL by Polichem S.A — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2009
Date Received
October 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type