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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 K053123
Device Name PD CATH
Applicant
MED-CONDUIT, INC.
18 DERBY LANE
TYNGSBORO,  MA  01879
Applicant Contact GERALD G BOUSQUET
Correspondent
MED-CONDUIT, INC.
18 DERBY LANE
TYNGSBORO,  MA  01879
Correspondent Contact GERALD G BOUSQUET
Regulation Number876.5630
Classification Product Code
FJS  
Date Received11/07/2005
Decision Date 03/29/2006
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
Predetermined Change
Control Plan Authorized		 No
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