510(k) K163093
K163093 is an FDA 510(k) premarket notification submitted by Jiangsu Shenli Medical Production Co., Ltd. for the device "Safety Blood Collection Set". The FDA issued a decision of Substantially Equivalent on March 14, 2017. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Jiangsu Shenli Medical Production Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2017
- Date Received
- November 4, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type