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510(k) K974387

PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE by Microwave Medical Systems, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1999
Date Received
November 21, 1997
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.

  • 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)
  • K900295 — PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES (November 21, 1990)

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