510(k) K182274
K182274 is an FDA 510(k) premarket notification submitted by Orbit Biomedical, Inc. for the device "Orbit Subretinal Delivery System". The FDA issued a decision of Substantially Equivalent - Kit on Nov 20, 2018. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Orbit Biomedical, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Nov 20, 2018
- Date Received
- Aug 22, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)