Clearance Summary
ASEPTICO ENDOPEX V, MODEL AEU-40 received FDA 510(k) clearance under submission number K030895, sponsored by Aseptico, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2003-12-03.
- Submission: K030895
- Applicant / Sponsor: Aseptico, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2003-12-03
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.