510(k) K063202

PRODERMA LIQUID BANDAGE by Procurement Technology Systems, LLC — Product Code KMF

K063202 is an FDA 510(k) premarket notification submitted by Procurement Technology Systems, LLC for the device "PRODERMA LIQUID BANDAGE". The FDA issued a decision of Substantially Equivalent on May 2, 2007. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2007
Date Received
October 20, 2006
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