The following data is part of a premarket notification filed by Zhejiang Gongdong Medical Technology Co., Ltd with the FDA for Sharps Container.
| Device ID | K201523 |
| 510k Number | K201523 |
| Device Name: | Sharps Container |
| Classification | Container, Sharps |
| Applicant | Zhejiang Gongdong Medical Technology Co., Ltd No.10, Beiyuan Avenue, Huangyan Taizhou, CN 318020 |
| Contact | Weifeng Zhong |
| Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, CN 200122 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-08 |
| Decision Date | 2020-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16947462492381 | K201523 | 000 |
| 06947462492353 | K201523 | 000 |
| 16947462492398 | K201523 | 000 |
| 16947462492374 | K201523 | 000 |
| 16947462492367 | K201523 | 000 |
| 16947462492343 | K201523 | 000 |
| 00840117338128 | K201523 | 000 |