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510(k) K813027

STERILE IRRIGATING SYRINGES, KITS,TRAY by Welcon, Inc. — Product Code KYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1981
Date Received
October 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Irrigating (Non Dental)
Device Class
Class I
Regulation Number
880.6960
Review Panel
HO
Submission Type

Other clearances by Welcon, Inc.

  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K912869 — WOMEN AND INFANT'S DELIVERY PACK (December 4, 1991)
  • K904158 — ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY (November 29, 1990)
  • K894397 — WELCON LIGHT HANDLE (August 10, 1989)
  • K830359 — STERILE CATHERIZATION PROCEDURE TRAYS (March 17, 1983)

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  • K974288 — ZEROWET SPLASHIELD (January 29, 1998)
  • K964833 — RMI DUAL FLUID IRRIGATING SYRINGE (February 19, 1997)
  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)