FDA 510(k) Application Details - K982220

Device Classification Name Pacemaker Lead Adaptor

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510(K) Number K982220
Device Name Pacemaker Lead Adaptor
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS, MN 55432-3576 US
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Contact BRIAN J EDWARDS
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Regulation Number 870.3620

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Classification Product Code DTD
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Date Received 06/24/1998
Decision Date 10/15/1998
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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