510(k) K003123
K003123 is an FDA 510(k) premarket notification submitted by Sunder Biomedical Tech. Co., Ltd. for the device "RENAX A.V. FISTULA NEEDLE SETS". The FDA issued a decision of Substantially Equivalent on May 4, 2001. The device falls under product code FIE (Needle, Fistula), a Class II device regulated under 21 CFR 876.5540. Sunder Biomedical Tech. Co., Ltd. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2001
- Date Received
- Oct 5, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Fistula
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
- 510(k)