Clearance Summary
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002 received FDA 510(k) clearance under submission number K982042, sponsored by Island Biosurgical, Inc.. 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 1998-09-08.
- Submission: K982042
- Applicant / Sponsor: Island Biosurgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 1998-09-08
Classification & Regulation
This clearance is catalogued under FDA product code OTN and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.