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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K092493
Device Name GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
Applicant
Gpc Medical, Ltd.
M-Block, Dda Lsc,
Vikas Puri, New Delhi,  IN 110018
Applicant Contact VIKAS NARANG
Correspondent
Gpc Medical, Ltd.
M-Block, Dda Lsc,
Vikas Puri, New Delhi,  IN 110018
Correspondent Contact VIKAS NARANG
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT  
Date Received08/14/2009
Decision Date 03/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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