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510(k) K033858

TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE by European Custom Manufacturing BV — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2004
Date Received
December 11, 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

Other clearances by European Custom Manufacturing BV

  • K080621 — FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 (April 29, 2008)

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