Clearance Summary
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) received FDA 510(k) clearance under submission number K961993, sponsored by Devon Industries, 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 1996-07-03.
- Submission: K961993
- Applicant / Sponsor: Devon Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1996-07-03
Classification & Regulation
This clearance is catalogued under FDA product code MLS and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.