510(k) K943619

CAVI-CARE CONFORMING FOAM DRESSING by Smith & Nephew United, Inc. — Product Code KMF

K943619 is an FDA 510(k) premarket notification submitted by Smith & Nephew United, Inc. for the device "CAVI-CARE CONFORMING FOAM DRESSING". The FDA issued a decision of SN on August 19, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Smith & Nephew United, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 19, 1994
Date Received
July 27, 1994
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