510(k) K183016
K183016 is an FDA 510(k) premarket notification submitted by Ocujet, LLC for the device "SteriCap Mini Needle". The FDA issued a decision of Substantially Equivalent on May 7, 2019. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ocujet, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 2019
- Date Received
- Oct 31, 2018
- Clearance Type
- Special
- 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)