Clearance Summary
APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE received FDA 510(k) clearance under submission number K891212, sponsored by Pro-Safe Professional Linens, 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 1989-04-14.
- Submission: K891212
- Applicant / Sponsor: Pro-Safe Professional Linens, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code FXO and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.