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 |