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510(k) K964833

RMI DUAL FLUID IRRIGATING SYRINGE by Research Medical, Inc. — Product Code KYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1997
Date Received
December 2, 1996
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

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  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (March 26, 1996)
  • K951344 — RMI HEMOCONCENTRATOR (August 15, 1995)
  • K922083 — RMI SURGICCAL SITE VISUALIZATION WAND (January 29, 1993)
  • K920936 — RMI EXTERNAL CORONARY ARTERY OCCLUDER (December 18, 1992)
  • K915869 — RMI NORMOCLUDER CORONARY ARTERY OCCLUDER (December 8, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K910221 — RMI VASCULAR TOURNIQUET KIT (May 16, 1991)
  • K901231 — RMI CARDIOPLEGIA DELIVERY KITS (June 8, 1990)

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  • K982435 — IRRIGATION SYRINGE KIT (November 6, 1998)
  • K974288 — ZEROWET SPLASHIELD (January 29, 1998)
  • K960725 — MARPP PRESSURE MONITORING SYSTEM (July 15, 1996)
  • K960212 — CPR IRRIGATION TRAY (April 1, 1996)
  • K952406 — REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLO (August 7, 1995)