Clearance Summary
MCGHAN TISSUE EXPANDER received FDA 510(k) clearance under submission number K843704, sponsored by Mcghan Medical 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 1984-10-31.
- Submission: K843704
- Applicant / Sponsor: Mcghan Medical Corp.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1984-10-31
Classification & Regulation
This clearance is catalogued under FDA product code LCJ , within the Unknown review panel as a device.