Clearance Summary
SWIFT DELIVERY PRODUCT #300 received FDA 510(k) clearance under submission number K973942, sponsored by Swift Delivery Products. 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 1997-12-12.
- Submission: K973942
- Applicant / Sponsor: Swift Delivery Products
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 1997-12-12
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.