Clearance Summary
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM received FDA 510(k) clearance under submission number K070313, sponsored by Misonix, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2007-05-11.
- Submission: K070313
- Applicant / Sponsor: Misonix, Inc.
- Clearance pathway: Special
- Review panel: Unknown
- Device class:
- Decision date: 2007-05-11
Classification & Regulation
This clearance is catalogued under FDA product code LFL , within the Unknown review panel as a device.