FDA 510(k) Application Details - K000210

Device Classification Name Pacemaker Lead Adaptor

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510(K) Number K000210
Device Name Pacemaker Lead Adaptor
Applicant MEDTRONIC VASCULAR
4000 LEXINGTON AVE. N
SHOREVIEW, MN 55126-2983 US
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Contact MICHAEL JOHNSON
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Regulation Number 870.3620

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Classification Product Code DTD
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Date Received 01/24/2000
Decision Date 02/23/2000
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Special
Reviewed By Third Party N
Expedited Review



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