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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K843807
Device Name SEAMED MODEL 6000
Applicant
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Applicant Contact WILLILAM J EVANS
Correspondent
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Correspondent Contact WILLILAM J EVANS
Regulation Number870.3600
Classification Product Code
DTE  
Date Received09/27/1984
Decision Date 02/01/1985
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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