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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, for peritoneal dialysis, disposable
510(k) Number K974387
Device Name PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
Applicant
MICROWAVE MEDICAL SYSTEMS, INC.
310-312 SCHOOL ST.
ACTON,  MA  01720
Applicant Contact RICHARD S GRABOWY
Correspondent
MICROWAVE MEDICAL SYSTEMS, INC.
310-312 SCHOOL ST.
ACTON,  MA  01720
Correspondent Contact RICHARD S GRABOWY
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received11/21/1997
Decision Date 09/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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