Clearance Summary
LATERAL RELEASE KNIFE 5MM & 7MM received FDA 510(k) clearance under submission number K841978, sponsored by Stainless Mfg., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1984-06-19.
- Submission: K841978
- Applicant / Sponsor: Stainless Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1984-06-19
Classification & Regulation
This clearance is catalogued under FDA product code HTZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.