510(k) K053409
K053409 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M LIQUID BANDAGE". The FDA issued a decision of Substantially Equivalent on June 19, 2006. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2006
- Date Received
- December 7, 2005
- 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