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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K003839
Device Name CENTRAL VENOUS CATHETER
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Applicant Contact THERESA A MCGOVERN
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,,  MA  01760
Correspondent Contact THERESA A MCGOVERN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/12/2000
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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