Clearance Summary
THE D & C PAD-SAC received FDA 510(k) clearance under submission number K862297, sponsored by Nu-Gyn-Tek, 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 1986-07-07.
- Submission: K862297
- Applicant / Sponsor: Nu-Gyn-Tek, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1986-07-07
Classification & Regulation
This clearance is catalogued under FDA product code HCY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.