Clearance Summary
PRESSURIZER, EXETER CEMENT received FDA 510(k) clearance under submission number K781792, sponsored by Howmedica Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-02-08.
- Submission: K781792
- Applicant / Sponsor: Howmedica Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1979-02-08
Classification & Regulation
This clearance is catalogued under FDA product code KIZ and 21 CFR 864.2240, within the Hematology review panel as a Class I device.