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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 K970159
Device Name FLEX-NECK PD CATHETER
Applicant
JANIN GROUP, INC.
615 ENTERPRISE ST.
AURORA,  IL  60504 -8138
Applicant Contact PAMELA L SWATKOWSKI
Correspondent
JANIN GROUP, INC.
615 ENTERPRISE ST.
AURORA,  IL  60504 -8138
Correspondent Contact PAMELA L SWATKOWSKI
Regulation Number876.5630
Classification Product Code
FJS  
Date Received01/16/1997
Decision Date 09/05/1997
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
Recalls CDRH Recalls
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