Clearance Summary
COMFORT PERSONAL LUBRICANT received FDA 510(k) clearance under submission number K915574, sponsored by Hyman, Phelps & McNamara, P.C.. 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 1993-02-19.
- Submission: K915574
- Applicant / Sponsor: Hyman, Phelps & McNamara, P.C.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6375
- Decision date: 1993-02-19
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.