510(k) K830811
K830811 is an FDA 510(k) premarket notification submitted by Steridoc Corp. for the device "ASEPTIC FLUID TRANSFER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code KQQ (Tubing, Dialysate (And Connector)), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1983
- Date Received
- March 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Dialysate (And Connector)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type