Clearance Summary
LATEX CONDOMS - CODE NO. 401, 421 & 1002 received FDA 510(k) clearance under submission number K901667, sponsored by Allercare/Nsl, 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 1990-05-16.
- Submission: K901667
- Applicant / Sponsor: Allercare/Nsl, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1990-05-16
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.