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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K042016
Device Name DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
Applicant
Datascope Corp.
1300 Macarthur Blvd.
Manwah,  NJ  07430
Applicant Contact PATRICE NAPODA
Correspondent
Datascope Corp.
1300 Macarthur Blvd.
Manwah,  NJ  07430
Correspondent Contact PATRICE NAPODA
Regulation Number876.5540
Classification Product Code
MSD  
Date Received07/27/2004
Decision Date 09/23/2004
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
Predetermined Change
Control Plan Authorized		 No
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