Clearance Summary
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT received FDA 510(k) clearance under submission number K905484, sponsored by Mentor Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1991-02-11.
- Submission: K905484
- Applicant / Sponsor: Mentor Corp.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1991-02-11
Classification & Regulation
This clearance is catalogued under FDA product code LCJ , within the Unknown review panel as a device.