The following data is part of a premarket notification filed by Jiangsu Shenli Medical Production Co., Ltd with the FDA for Safety Blood Collection Set.
| Device ID | K163093 |
| 510k Number | K163093 |
| Device Name: | Safety Blood Collection Set |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Jiangsu Shenli Medical Production Co., Ltd No 20, Changzheng Road, Zhenglu Changzhou City, CN 213111 |
| Contact | Tina Cai |
| Correspondent | Charles Mack IRC 7808 Rush Creek Drive Pasco, WA 99301 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2017-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16935550817024 | K163093 | 000 |
| 16935550817017 | K163093 | 000 |
| 20853620005412 | K163093 | 000 |
| 20853620005405 | K163093 | 000 |
| 10850011007270 | K163093 | 000 |
| 10850011007263 | K163093 | 000 |
| 10850011007256 | K163093 | 000 |