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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Rongeur, Manual
510(k) Number K081651
Device Name INSTRUMED RONGEUR
Applicant
INSTRUMED INTERNATIONAL, INC.
626 COOPER COURT
SCHAUMBURG,  IL  60173
Applicant Contact MICHAEL MASSONG
Correspondent
INSTRUMED INTERNATIONAL, INC.
626 COOPER COURT
SCHAUMBURG,  IL  60173
Correspondent Contact MICHAEL MASSONG
Regulation Number882.4840
Classification Product Code
HAE  
Date Received06/12/2008
Decision Date 08/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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