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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 K854648
Device Name SEAMED MODEL 4000
Applicant
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Applicant Contact DAN ROPER
Correspondent
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Correspondent Contact DAN ROPER
Regulation Number870.3600
Classification Product Code
DTE  
Date Received11/19/1985
Decision Date 01/16/1986
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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