Clearance Summary
DENTAL SURGICAL WRAP #3007 A,B,C received FDA 510(k) clearance under submission number K891214, sponsored by Pro-Safe Professional Linens, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1989-04-14.
- Submission: K891214
- Applicant / Sponsor: Pro-Safe Professional Linens, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.