510(k) K083531

LIQUIBAND ULTIMA, MODEL LB0004 by Medlogic Global , Ltd. — Product Code MPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2009
Date Received
November 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Device Class
Class II
Regulation Number
878.4010
Review Panel
SU
Submission Type

Docket number: 2006p-0071 - may 5, 2008 - reclassified from class 3 pma to class 2 510(k).