The following data is part of a premarket notification filed by Sunder Biomedical Tech. Co., Ltd. with the FDA for Sunder Central Venous Catheter Kit, Models Sd-3l55f30j And Sd-3l70f30j.
| Device ID | K024007 |
| 510k Number | K024007 |
| Device Name: | SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-07-14 |
| Summary: | summary |