Clearance Summary
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 received FDA 510(k) clearance under submission number K052870, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-09-29.
- Submission: K052870
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4370
- Decision date: 2006-09-29
Classification & Regulation
This clearance is catalogued under FDA product code NZP and 21 CFR 878.4370, within the General, Plastic Surgery review panel as a Class II device.