510(k) K940407

KALTOGEL WOUND DRESSING by Calgon Corp. — Product Code KMF

K940407 is an FDA 510(k) premarket notification submitted by Calgon Corp. for the device "KALTOGEL WOUND DRESSING". The FDA issued a decision of SN on April 7, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Calgon Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 7, 1994
Date Received
January 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