Clearance Summary
CAREFREE * PANTY SHIELDS-REG/DEOR received FDA 510(k) clearance under submission number K832382, sponsored by Johnson & Johnson Professionals, 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 1983-08-12.
- Submission: K832382
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5425
- Decision date: 1983-08-12
Classification & Regulation
This clearance is catalogued under FDA product code HHL and 21 CFR 884.5425, within the Obstetrics/Gynecology review panel as a Class II device.