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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Obstetrical
510(k) Number K100517
Device Name INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
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 Number884.4400
Classification Product Code
HDA  
Date Received02/23/2010
Decision Date 04/29/2010
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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