Clearance Summary
PARACERVICAL/PUDENDAL TRAYS received FDA 510(k) clearance under submission number K896799, sponsored by Westmark, Sterile Packing Systems, Inc. (Sps). The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1990-04-23.
- Submission: K896799
- Applicant / Sponsor: Westmark, Sterile Packing Systems, Inc. (Sps)
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 1990-04-23
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.