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510(k) K871630

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

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

Other clearances by Dove Medical Supplies

  • K883068 — HEMODIALYSIS CONCENTRATES (December 22, 1988)

Other clearances for product code FKG

  • K925469 — JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (May 3, 1995)
  • K833780 — CAPD PREP KIT (February 9, 1984)
  • K802361 — DIALYIS START CARE KIT (January 16, 1981)
  • K792207 — PERIDIAL PERITONEAL DIALYSIS TRAY (December 10, 1979)
  • K790353 — ACUTE RENAL DIALYSIS TRAY (April 20, 1979)