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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 K130441
Device Name FALLER STYLET
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
FJS  
Date Received02/21/2013
Decision Date 04/19/2013
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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