Clearance Summary
MEDICOOL PROTECTALL received FDA 510(k) clearance under submission number K934703, sponsored by Avc Regulatory Compliance/Technical Services. 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 1994-01-26.
- Submission: K934703
- Applicant / Sponsor: Avc Regulatory Compliance/Technical Services
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class:
- Decision date: 1994-01-26
Classification & Regulation
This clearance is catalogued under FDA product code LDQ , within the General Hospital review panel as a device.