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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K032600
Device Name VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
Applicant
Boston Scientific Corp
10 Glens Falls Technical Park
Glens Falls,  NY  12801 -3864
Applicant Contact JODI LYNN GREENIZEN
Correspondent
Boston Scientific Corp
10 Glens Falls Technical Park
Glens Falls,  NY  12801 -3864
Correspondent Contact JODI LYNN GREENIZEN
Regulation Number880.5965
Classification Product Code
LJT  
Date Received08/25/2003
Decision Date 09/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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