510(k) K942270

SAF-GEL HYDRATING DERMAL WOUND DRESSING by Calgon Vestal Div. — Product Code KMF

K942270 is an FDA 510(k) premarket notification submitted by Calgon Vestal Div. for the device "SAF-GEL HYDRATING DERMAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 4, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Calgon Vestal Div. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1994
Date Received
May 10, 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