510(k) K071735
K071735 is an FDA 510(k) premarket notification submitted by Symbios Medical Products, LLC for the device "MODIFICATION TO DISPOSABLE INFUSION PUMP KIT". The FDA issued a decision of Substantially Equivalent on July 19, 2007. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Symbios Medical Products, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2007
- Date Received
- June 26, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type