Clearance Summary
OBSTETRICAL KIT received FDA 510(k) clearance under submission number K822505, sponsored by Parr Emergency Product Sales, 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 1982-09-30.
- Submission: K822505
- Applicant / Sponsor: Parr Emergency Product Sales, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1982-09-30
Classification & Regulation
This clearance is catalogued under FDA product code HHD and 21 CFR 884.5435, within the Obstetrics/Gynecology review panel as a Class I device.