510(k) K871630

KITS AND TRAYS FOR DIALYSIS USE by Dove Medical Supplies — Product Code FKG

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