Clearance Summary
FELDMAN MINI-SAW, #300000 received FDA 510(k) clearance under submission number K800669, sponsored by KARL STORZ Endoscopy-America, Inc.. 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 1980-04-21.
- Submission: K800669
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1980-04-21
Classification & Regulation
This clearance is catalogued under FDA product code EWQ and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.