510(k) K925937

WELLS LAMONT HANDAGES/MED WRAP DRESSINGS by Wells Lamont Corp. — Product Code KMF

K925937 is an FDA 510(k) premarket notification submitted by Wells Lamont Corp. for the device "WELLS LAMONT HANDAGES/MED WRAP DRESSINGS". The FDA issued a decision of Substantially Equivalent on August 9, 1993. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Wells Lamont Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
November 24, 1992
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