The following data is part of a premarket notification filed by Chengdu Shifeng Medical Technology Co., Ltd. with the FDA for Rg 3ml Medication Cartridge.
| Device ID | K201634 |
| 510k Number | K201634 |
| Device Name: | RG 3ml Medication Cartridge |
| Classification | Accessories, Pump, Infusion |
| Applicant | Chengdu Shifeng Medical Technology Co., Ltd. No. 31, Yinyuan Road Jinhua Town, Xinjin County, CN 611438 |
| Contact | Nick Wang |
| Correspondent | Maureen O'connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | MRZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2021-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G002RG30 | K201634 | 000 |