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510(k) K900295

PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES by Microwave Medical Systems, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1990
Date Received
January 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Microwave Medical Systems, Inc.

  • K974387 — PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET (September 1, 1999)
  • K932083 — XDCS-100 (December 16, 1993)
  • K914867 — QWIK-1(TM) IN-LINE IV FLUID WARMER (October 23, 1992)
  • K913110 — PDM-1 DEVICE:CAPD DISINFECTING DEVICE, MODIFIED (October 10, 1991)

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