510(k) K993039
K993039 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)". The FDA issued a decision of Substantially Equivalent on January 7, 2000. The device falls under product code MRH (Pump, Infusion, Ophthalmic), a Class II device regulated under 21 CFR 880.5725. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2000
- Date Received
- September 10, 1999
- 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