Clearance Summary
LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 received FDA 510(k) clearance under submission number K031321, sponsored by Medlogic Global Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-01-21.
- Submission: K031321
- Applicant / Sponsor: Medlogic Global Limited
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 2004-01-21
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.