Clearance Summary
CONDOM-MATE VAGINAL LUBRICANT received FDA 510(k) clearance under submission number K881338, sponsored by Upsher-Smith Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1988-05-16.
- Submission: K881338
- Applicant / Sponsor: Upsher-Smith Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1988-05-16
Classification & Regulation
This clearance is catalogued under FDA product code KMJ and 21 CFR 880.6375, within the General Hospital review panel as a Class I device.