Clearance Summary
ALLEN MALLEABLE ANESTHESIA SCREEN received FDA 510(k) clearance under submission number K873370, sponsored by Edgewater Medical Equipment Systems. 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 1987-09-11.
- Submission: K873370
- Applicant / Sponsor: Edgewater Medical Equipment Systems
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1987-09-11
Classification & Regulation
This clearance is catalogued under FDA product code FWZ and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.