Clearance Summary
HEMOSTAT received FDA 510(k) clearance under submission number K770158, sponsored by Deringer-Ney, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-01-31.
- Submission: K770158
- Applicant / Sponsor: Deringer-Ney, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1977-01-31
Classification & Regulation
This clearance is catalogued under FDA product code EMD and 21 CFR 872.4565, within the Dental review panel as a Class I device.