Clearance Summary
TABLE, OPERATING, FIELD 6530-00-709-8155 received FDA 510(k) clearance under submission number K821924, sponsored by Emerson-Sack-Warner Corp.. 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 1982-07-13.
- Submission: K821924
- Applicant / Sponsor: Emerson-Sack-Warner Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4950
- Decision date: 1982-07-13
Classification & Regulation
This clearance is catalogued under FDA product code FSE and 21 CFR 878.4950, within the General, Plastic Surgery review panel as a Class I device.