Clearance Summary
NON-LINTING DELIVERY BLANKET received FDA 510(k) clearance under submission number K932035, sponsored by Amsco Sterile Recoveries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1994-05-26.
- Submission: K932035
- Applicant / Sponsor: Amsco Sterile Recoveries, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1994-05-26
Classification & Regulation
This clearance is catalogued under FDA product code KNC and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.