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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, Short-Term Less Than 30 Days
510(k) Number K033853
Device Name MODIFICATION TO V-CATH POLY PICC
Applicant
Hdc Corp.
628 Gibraltar Ct.
Milpitas,  CA  95035
Applicant Contact EARL SMART
Correspondent
Hdc Corp.
628 Gibraltar Ct.
Milpitas,  CA  95035
Correspondent Contact EARL SMART
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/11/2003
Decision Date 01/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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