510(k) K833780
K833780 is an FDA 510(k) premarket notification submitted by Professional Dialysis Products for the device "CAPD PREP KIT". The FDA issued a decision of Substantially Equivalent on February 9, 1984. The device falls under product code FKG (Tray, Start/Stop (Including Contents), Dialysis), a Class I device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1984
- Date Received
- October 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Start/Stop (Including Contents), Dialysis
- Device Class
- Class I
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type