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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K040162
Device Name CORRESTORE PATCH SYSTEM
Applicant
Somanetics Corp.
1653 E. Maple Rd.
Troy,  MI  48083 -4208
Applicant Contact RONALD A WIDMAN
Correspondent
Somanetics Corp.
1653 E. Maple Rd.
Troy,  MI  48083 -4208
Correspondent Contact RONALD A WIDMAN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received01/26/2004
Decision Date 03/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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