510(k) K050716
K050716 is an FDA 510(k) premarket notification submitted by Iscience Surgical Corporation for the device "ISCIENCE SURGICAL VISCOINJECTOR". The FDA issued a decision of Substantially Equivalent on April 21, 2005. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Iscience Surgical Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2005
- Date Received
- March 21, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- OP
- Submission Type