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510(k) K792207

PERIDIAL PERITONEAL DIALYSIS TRAY by Cutter Laboratories, Inc. — Product Code FKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1979
Date Received
November 2, 1979
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 Cutter Laboratories, Inc.

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  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)

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)
  • K802361 — DIALYIS START CARE KIT (January 16, 1981)
  • K790353 — ACUTE RENAL DIALYSIS TRAY (April 20, 1979)