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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K091781
FOIA Releasable 510(k) K091781
Device Name GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
Applicant
Mediguide, Ltd.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Mediguide, Ltd.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/17/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00840619
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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