510(k) K051082

MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) by Medtrade Products , Ltd. — Product Code KMF

K051082 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)". The FDA issued a decision of Substantially Equivalent on November 8, 2005. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2005
Date Received
April 27, 2005
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