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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Surgical, Gynecological
510(k) Number K092840
Device Name INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
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 Number884.4530
Classification Product Code
HCZ  
Date Received09/15/2009
Decision Date 12/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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