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FDA 510(k) Application Details - K960281
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K960281
Device Name
Permanent Pacemaker Electrode
Applicant
INTERMEDICS, INC.
4000 TECHNOLOGY DR.
ANGLETON, TX 77515 US
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Contact
LORI KLEINSCHRODT HOLDER
Other 510(k) Applications for this Contact
Regulation Number
870.3680
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Classification Product Code
DTB
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More FDA Info for this Product Code
Date Received
01/19/1996
Decision Date
06/18/1996
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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