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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K913386
Device Name CHEMO-PORT
Applicant
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Applicant Contact GRETCHEN MARCHESANI
Correspondent
Hdc Corp.
2109 O'Toole Ave.
San Jose,  CA  95131
Correspondent Contact GRETCHEN MARCHESANI
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/29/1991
Decision Date 01/10/1992
Decision Substantially Equivalent - Kit (SESK)
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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