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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peritoneal, long-term indwelling
510(k) Number K993149
Device Name PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
Applicant
MEDIONICS INTERNATIONAL, INC.
114 ANDERSON AVE.
MARKHAM, ONTARIO,  CA L6E 1A5
Applicant Contact MASHESH AGARWAL
Correspondent
MEDIONICS INTERNATIONAL, INC.
114 ANDERSON AVE.
MARKHAM, ONTARIO,  CA L6E 1A5
Correspondent Contact MASHESH AGARWAL
Regulation Number876.5630
Classification Product Code
FJS  
Date Received09/21/1999
Decision Date 04/28/2000
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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