Clearance Summary
PLASTIC DISPOSABLE RAZOR received FDA 510(k) clearance under submission number K831799, sponsored by I M, Inc.. 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 1983-07-18.
- Submission: K831799
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1983-07-18
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.