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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K853850
Device Name EXPLORER
Applicant
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact BRUCE BEAUCHEMIN
Correspondent
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact BRUCE BEAUCHEMIN
Regulation Number870.3680
Classification Product Code
DTB  
Date Received09/16/1985
Decision Date 12/04/1985
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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