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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 K873165
Device Name CHEMO-PORT NON-CORING NEEDLES
Applicant
Hdc Corp.
2551 Casey Ave.
Mountain View,  CA  94043
Applicant Contact WILLIAM J SCHRODER
Correspondent
Hdc Corp.
2551 Casey Ave.
Mountain View,  CA  94043
Correspondent Contact WILLIAM J SCHRODER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/11/1987
Decision Date 12/03/1987
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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