Clearance Summary
SELF-CONTAINED SURGICAL SLUSH FREEZER received FDA 510(k) clearance under submission number K913777, sponsored by Taylor Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1991-09-25.
- Submission: K913777
- Applicant / Sponsor: Taylor Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2050
- Decision date: 1991-09-25
Classification & Regulation
This clearance is catalogued under FDA product code JRM and 21 CFR 862.2050, within the Clinical Chemistry review panel as a Class I device.