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510(k) K802361

DIALYIS START CARE KIT by Med-Pak Corp. — Product Code FKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1981
Date Received
September 26, 1980
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 Med-Pak Corp.

  • K884425 — GLOVE, SURGICAL (February 6, 1989)

Other clearances for product code FKG

  • K925469 — JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (May 3, 1995)
  • K871630 — KITS AND TRAYS FOR DIALYSIS USE (May 26, 1987)
  • K833780 — CAPD PREP KIT (February 9, 1984)
  • K792207 — PERIDIAL PERITONEAL DIALYSIS TRAY (December 10, 1979)
  • K790353 — ACUTE RENAL DIALYSIS TRAY (April 20, 1979)