Clearance Summary
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES received FDA 510(k) clearance under submission number K910781, sponsored by Midmark Corp.. 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 1991-05-15.
- Submission: K910781
- Applicant / Sponsor: Midmark Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5300
- Decision date: 1991-05-15
Classification & Regulation
This clearance is catalogued under FDA product code ETF and 21 CFR 874.5300, within the Ear, Nose, Throat review panel as a Class I device.