510(k) K042900
K042900 is an FDA 510(k) premarket notification submitted by K.E.P., LLC for the device "K.E.P. CONNECTOR AND CLIP". The FDA issued a decision of Substantially Equivalent on November 5, 2004. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2004
- Date Received
- October 19, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, For Peritoneal Dialysis, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type