Clearance Summary
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE received FDA 510(k) clearance under submission number K933770, sponsored by Mahe-Medizintechnik. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-03-23.
- Submission: K933770
- Applicant / Sponsor: Mahe-Medizintechnik
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1994-03-23
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.