Clearance Summary
TLS TM SURGICAL DRAINAGE SYSTEM received FDA 510(k) clearance under submission number K800581, sponsored by Glasrock Products, 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 1980-04-04.
- Submission: K800581
- Applicant / Sponsor: Glasrock Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4680
- Decision date: 1980-04-04
Classification & Regulation
This clearance is catalogued under FDA product code GCY and 21 CFR 878.4680, within the General, Plastic Surgery review panel as a Class I device.