Clearance Summary
HOSPITAL KIT ENT 1125 received FDA 510(k) clearance under submission number K922126, sponsored by Savoy Medical Supply Co., 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 1993-01-21.
- Submission: K922126
- Applicant / Sponsor: Savoy Medical Supply Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1993-01-21
Classification & Regulation
This clearance is catalogued under FDA product code LRP and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.