Clearance Summary
MANAN PROSTATE UNI-LOCK received FDA 510(k) clearance under submission number K963743, sponsored by Manan Medical Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-12-06.
- Submission: K963743
- Applicant / Sponsor: Manan Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5650
- Decision date: 1996-12-06
Classification & Regulation
This clearance is catalogued under FDA product code IWJ and 21 CFR 892.5650, within the Radiology review panel as a Class I device.