The following data is part of a premarket notification filed by Sunder Biomedical Tech. Co., Ltd. with the FDA for Renax A.v. Fistula Needle Sets.
| Device ID | K003123 |
| 510k Number | K003123 |
| Device Name: | RENAX A.V. FISTULA NEEDLE SETS |
| Classification | Needle, Fistula |
| Applicant | SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. Taichung City, TW 403 |
| Contact | Tony Hung |
| Correspondent | Tony Hung SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. Taichung City, TW 403 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-05 |
| Decision Date | 2001-05-04 |