Submission Details
| 510(k) Number | K201634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 16, 2020 |
| Decision Date | March 26, 2021 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
RG 3ml Medication Cartridge
Mar 2021
Decision
283d
Days
Class 2
Risk
About This 510(k) Submission
K201634 is an FDA 510(k) clearance for the RG 3ml Medication Cartridge, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Chengdu Shifeng Medical Technology Co., Ltd. (Jinhua Town, Xinjin County, CN). The FDA issued a Cleared decision on March 26, 2021, 283 days after receiving the submission on June 16, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.
Device Classification
| Product Code | MRZ — Accessories, Pump, Infusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
Manufacturer
Chengdu Shifeng Medical Technology Co., Ltd.
Jinhua Town, Xinjin County · CN
Nick Wang
1 submissions
1 cleared
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