Clearance Summary
STERILE PAN SET received FDA 510(k) clearance under submission number K842136, sponsored by Medi-Plast Intl., Inc.. 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 1984-07-06.
- Submission: K842136
- Applicant / Sponsor: Medi-Plast Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 1984-07-06
Classification & Regulation
This clearance is catalogued under FDA product code FRG and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.