510(k) K153571

Cavilon Advanced High Endurance Skin Protectant by 3M Healthcare — Product Code KMF

K153571 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "Cavilon Advanced High Endurance Skin Protectant". The FDA issued a decision of Substantially Equivalent on August 23, 2016. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. 3M Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2016
Date Received
December 15, 2015
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