Clearance Summary
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC received FDA 510(k) clearance under submission number K951064, sponsored by S-E Sales & Distribution, 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 1995-05-19.
- Submission: K951064
- Applicant / Sponsor: S-E Sales & Distribution, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1995-05-19
Classification & Regulation
This clearance is catalogued under FDA product code FTY and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.