Clearance Summary
SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK received FDA 510(k) clearance under submission number K935391, sponsored by 3M Health Care, Sarns. 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 1994-02-24.
- Submission: K935391
- Applicant / Sponsor: 3M Health Care, Sarns
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1994-02-24
Classification & Regulation
This clearance is catalogued under FDA product code GFA and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.