Clearance Summary
J-VAC BULB SUCTION RESERVOIR received FDA 510(k) clearance under submission number K922895, sponsored by Johnson & Johnson Medical, 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 1992-09-15.
- Submission: K922895
- Applicant / Sponsor: Johnson & Johnson Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4680
- Decision date: 1992-09-15
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.