510(k) K981907
K981907 is an FDA 510(k) premarket notification submitted by Peregrine Surgical , Ltd. for the device "V.F.I.-VISCOUS FLUID INFUSION TUBING SET". The FDA issued a decision of Substantially Equivalent on August 4, 1998. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Peregrine Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1998
- Date Received
- June 1, 1998
- 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