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510(k) K032613

TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE by Peter M. Rothenberg, M.D. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2003
Date Received
August 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type

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