FDA 510(k) Application Details - K874498

Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intraventricular

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510(K) Number K874498
Device Name Port & Catheter, Implanted, Subcutaneous, Intraventricular
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
P.O. BOX 2090
GOLETA, CA US
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Contact W LAGUETTE
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Regulation Number 000.0000

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Classification Product Code LKG
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Date Received 11/02/1987
Decision Date 02/11/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee -
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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