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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name retractor, self-retaining, for neurosurgery
510(k) Number K071771
Device Name INSTRUMED RETRACTORS
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 Number882.4800
Classification Product Code
GZT  
Date Received06/29/2007
Decision Date 08/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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