Clearance Summary
OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP received FDA 510(k) clearance under submission number K935531, sponsored by Puritas Health Care, 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 1994-05-05.
- Submission: K935531
- Applicant / Sponsor: Puritas Health Care, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1994-05-05
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.