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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 K011487
Device Name CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS
Applicant
Somanetics Corp.
1653 E. Maple Rd.
Troy,  MI  48083
Applicant Contact RONALD A WIDMAN
Correspondent
Somanetics Corp.
1653 E. Maple Rd.
Troy,  MI  48083
Correspondent Contact RONALD A WIDMAN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received05/15/2001
Decision Date 11/21/2001
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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