510(k) K923299

APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK by Aplicare, Inc. — Product Code KMF

K923299 is an FDA 510(k) premarket notification submitted by Aplicare, Inc. for the device "APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK". The FDA issued a decision of Substantially Equivalent on January 18, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Aplicare, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1994
Date Received
July 6, 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