510(k) K124024
K124024 is an FDA 510(k) premarket notification submitted by Fresensius Medical Care North America for the device "APD LUER-LOCK ADAPTER". The FDA issued a decision of Substantially Equivalent on September 19, 2013. 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
- September 19, 2013
- Date Received
- December 28, 2012
- 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