Clearance Summary
BIAS STOCKINETTE received FDA 510(k) clearance under submission number K820141, sponsored by Stan-Pak Ent.. 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 1982-02-05.
- Submission: K820141
- Applicant / Sponsor: Stan-Pak Ent.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5075
- Decision date: 1982-02-05
Classification & Regulation
This clearance is catalogued under FDA product code FQM and 21 CFR 880.5075, within the General Hospital review panel as a Class I device.