Clearance Summary
HYPO SUTURE received FDA 510(k) clearance under submission number K834138, sponsored by Medical Design & Manufacturing Corp.. 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 1984-01-27.
- Submission: K834138
- Applicant / Sponsor: Medical Design & Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 878.4740
- Decision date: 1984-01-27
Classification & Regulation
This clearance is catalogued under FDA product code GAG and 21 CFR 878.4740, within the General Hospital review panel as a Class II device.