510(k) K850729
K850729 is an FDA 510(k) premarket notification submitted by Surgidev Corp. for the device "ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000". The FDA issued a decision of Substantially Equivalent on April 9, 1985. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Surgidev Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1985
- Date Received
- February 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type