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510(k) K925469

JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT by J.J. Skinner, Inc. — Product Code FKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
October 29, 1992
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 J.J. Skinner, Inc.

  • K961227 — JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY (June 10, 1996)
  • K961683 — JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY (May 10, 1996)
  • K925467 — JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT (May 11, 1994)
  • K925468 — JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (April 11, 1994)
  • K903545 — CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS (November 13, 1990)
  • K903544 — CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS (August 31, 1990)

Other clearances for product code FKG

  • K871630 — KITS AND TRAYS FOR DIALYSIS USE (May 26, 1987)
  • 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)