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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 K071875
Device Name 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 Number880.5970
Classification Product Code
LJS  
Date Received07/06/2007
Decision Date 11/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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