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510(k) K053169

RM3 RENAL PRESERVATION SYSTEM by Waters Instruments, Inc. — Product Code KDK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2006
Date Received
November 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Transport, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

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  • K841876 — POLYURETHANE THERMAL DILUTION CATHET (July 13, 1984)
  • K813585 — WATERS ILEOSTOMY VALVE (April 9, 1982)

Other clearances for product code KDK

  • K911577 — HYPOTRANS MODEL 750 (July 8, 1992)
  • K801899 — KEITHLEY LYMPHOCYTE DEPLETION CART (September 26, 1980)