Clearance Summary
OLYMPIC WARMETTE received FDA 510(k) clearance under submission number K911955, sponsored by Olympic Medical 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 1991-07-19.
- Submission: K911955
- Applicant / Sponsor: Olympic Medical Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1991-07-19
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.