510(k) K014140
K014140 is an FDA 510(k) premarket notification submitted by Sunder Biomedical Tech. Co., Ltd. for the device "RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET". The FDA issued a decision of Substantially Equivalent on Nov 18, 2002. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Sunder Biomedical Tech. Co., Ltd. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2002
- Date Received
- Dec 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)