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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 K012502
Device Name MEDIGROUP CATHETER EXTENDER/REPAIR KIT
Applicant
JANIN GROUP, INC.
505 WESTON RIDGE DR.
NAPERVILLE,  IL  60563 -3932
Applicant Contact JOHN A NAVIS
Correspondent
JANIN GROUP, INC.
505 WESTON RIDGE DR.
NAPERVILLE,  IL  60563 -3932
Correspondent Contact JOHN A NAVIS
Regulation Number876.5630
Classification Product Code
FJS  
Date Received08/03/2001
Decision Date 02/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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