Clearance Summary
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA received FDA 510(k) clearance under submission number K991381, sponsored by Pacific Andrology, 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 1999-09-24.
- Submission: K991381
- Applicant / Sponsor: Pacific Andrology, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 1999-09-24
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.