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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K924388
Device Name ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD
Applicant
Angemed, Inc.
3650 Annapolis Ln.
Minneapolis,  MN  55447
Applicant Contact TOM THOMPSON
Correspondent
Angemed, Inc.
3650 Annapolis Ln.
Minneapolis,  MN  55447
Correspondent Contact TOM THOMPSON
Regulation Number870.3680
Classification Product Code
LDF  
Date Received08/31/1992
Decision Date 10/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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