510(k) K910927

SPENCIO SKIN GUARD KIT by Spenco Medical Corp. — Product Code KMF

K910927 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "SPENCIO SKIN GUARD KIT". The FDA issued a decision of Substantially Equivalent on June 3, 1991. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1991
Date Received
March 5, 1991
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