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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K945473
Device Name V-CATH BREAKAWAY NEEDLE INTRODUCER
Applicant
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Applicant Contact GRETHEN MARCHESANI
Correspondent
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Correspondent Contact GRETHEN MARCHESANI
Regulation Number880.6920
Classification Product Code
KZH  
Date Received11/08/1994
Decision Date 01/20/1995
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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