FDA 510(k) Application Details - K983331

Device Classification Name Catheter, Ventricular

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510(K) Number K983331
Device Name Catheter, Ventricular
Applicant MEDTRONIC PS MEDICAL
125 CREMONA DR.
GOLETA, CA 93117-5500 US
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Contact JEFFREY HENDERSON
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Regulation Number 882.4100

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Classification Product Code HCA
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Date Received 09/22/1998
Decision Date 12/16/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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