Clearance Summary
MR. RAZOR II TWIN received FDA 510(k) clearance under submission number K882388, sponsored by Burney Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-07-13.
- Submission: K882388
- Applicant / Sponsor: Burney Products Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1988-07-13
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.