510(k) K922540

WOUND DRESSING by Les Laboratorires Brothier, S.A. — Product Code KMF

K922540 is an FDA 510(k) premarket notification submitted by Les Laboratorires Brothier, S.A. for the device "WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 24, 1992. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Les Laboratorires Brothier, S.A. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1992
Date Received
May 29, 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