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FDA 510(k) Application Details - K982220
Device Classification Name
Pacemaker Lead Adaptor
More FDA Info for this Device
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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More FDA Info for this Product Code
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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