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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 K945567
Device Name QC CAP
Applicant
Medionics International, Inc.
114 Anderson Ave.
Markham, Ontario,  CA L6E 1A5
Applicant Contact MAHESH AGARWAL
Correspondent
Medionics International, Inc.
114 Anderson Ave.
Markham, Ontario,  CA L6E 1A5
Correspondent Contact MAHESH AGARWAL
Regulation Number876.5630
Classification Product Code
KDJ  
Date Received09/27/1994
Decision Date 02/07/1995
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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