510(k) K910927
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