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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 K915364
Device Name CHRONOCOR VI MODEL 5012
Applicant
Seamed Corp.
11810 N. Creek Pkwy.
North
Bothell,  WA  98011
Applicant Contact MARCIA PAGE
Correspondent
Seamed Corp.
11810 N. Creek Pkwy.
North
Bothell,  WA  98011
Correspondent Contact MARCIA PAGE
Regulation Number870.3600
Classification Product Code
DTE  
Date Received11/27/1991
Decision Date 02/07/1992
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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