510(k) K871630
K871630 is an FDA 510(k) premarket notification submitted by Dove Medical Supplies for the device "KITS AND TRAYS FOR DIALYSIS USE". The FDA issued a decision of Substantially Equivalent on May 26, 1987. The device falls under product code FKG (Tray, Start/Stop (Including Contents), Dialysis), a Class I device regulated under 21 CFR 876.5820. Dove Medical Supplies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1987
- Date Received
- April 27, 1987
- 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