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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 K900295
Device Name PERITONEAL DIALYSIS STYSTEM AND ACCESSORIES
Applicant
Microwave Medical Systems, Inc.
9 Goldsmith St.
P.O. Box 188
Littleton,  MA  01460
Applicant Contact RICHARD S GRABOWY
Correspondent
Microwave Medical Systems, Inc.
9 Goldsmith St.
P.O. Box 188
Littleton,  MA  01460
Correspondent Contact RICHARD S GRABOWY
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received01/22/1990
Decision Date 11/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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