510(k) K233794
K233794 is an FDA 510(k) premarket notification submitted by Spm Medicare Pvt. , Ltd. for the device "Insulin Syringe". The FDA issued a decision of Substantially Equivalent on March 6, 2024. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Spm Medicare Pvt. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2024
- Date Received
- November 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type