Clearance Summary
MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES received FDA 510(k) clearance under submission number K003695, sponsored by Micro-Medical Devices, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-02-14.
- Submission: K003695
- Applicant / Sponsor: Micro-Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2001-02-14
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.