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510(k) K844612

ACUTE HEMODIALYSIS TRAYS by Packaging Technologies, Inc. — Product Code KNZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
November 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, A-V Shunt
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Packaging Technologies, Inc.

  • K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
  • K863326 — BONE MARROW TRAY (September 16, 1986)
  • K861041 — ENHANCE (May 30, 1986)
  • K850544 — SHAVE PREP TRAY (March 12, 1985)
  • K850438 — RENAL BIOPSY TRAY (February 26, 1985)
  • K844613 — GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (January 10, 1985)
  • K844614 — IV START KIT (December 19, 1984)
  • K844611 — SINGLE BASIN SET (December 19, 1984)
  • K834074 — PERCUTANEOUS SHEATH INTRODUCER TRAY (March 19, 1984)
  • K834073 — CENTRAL VEIN CATHERIZATION TRAY CC-20 (February 28, 1984)

Other clearances for product code KNZ

  • K842039 — ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (January 29, 1985)
  • K842864 — VACCESS FEMORAL CANNULA (August 8, 1984)
  • K842416 — DUO FLOW CATHETER-MC 54 (July 26, 1984)
  • K841530 — DOUBLE LUMEN SUBLCAVIAN-FEMORAL (June 25, 1984)
  • K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS (April 20, 1984)
  • K840424 — HEMOCATH REPAIR KIT (March 5, 1984)
  • K840437 — HEMASITE ACCESSORIES MODIFICATION (February 21, 1984)
  • K834510 — RENAFLO AVF SET FOR HEMODIALYSIS (February 4, 1984)
  • K833139 — ACUTE HEMODIALYSIS TRAYS (December 22, 1983)