510(k) K983554

ALLDRESS, ABSORBENT FILM DRESSING by Molnlycke Health Care, Inc. — Product Code KMF

K983554 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care, Inc. for the device "ALLDRESS, ABSORBENT FILM DRESSING". The FDA issued a decision of SN on November 10, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Molnlycke Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 10, 1998
Date Received
October 13, 1998
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