Clearance Summary
PALCO LABS COLD POUCH received FDA 510(k) clearance under submission number K942810, sponsored by Palco Laboratories, 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 1995-06-28.
- Submission: K942810
- Applicant / Sponsor: Palco Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1995-06-28
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.