510(k) K002338
K002338 is an FDA 510(k) premarket notification submitted by Closure Medical Corp. for the device "LIQUIDERM LIQUID ADHESIVE BANDAGE". The FDA issued a decision of Substantially Equivalent on January 29, 2001. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Closure Medical Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 2001
- Date Received
- August 1, 2000
- 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