510(k) K223327
K223327 is an FDA 510(k) premarket notification submitted by Shanghai Kindly Enterprise Development Group Co., Ltd. for the device "Sterile Aesthetic Cannula and Hypodermic Needle". The FDA issued a decision of Substantially Equivalent on Feb 16, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Shanghai Kindly Enterprise Development Group Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 2023
- Date Received
- Oct 31, 2022
- 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
- 510(k)