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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 K101400
Device Name LOCKING COMPRESSION PLATE
Applicant
Changzhou Orthmed Medical Instrument Co., Ltd.
Zhongshan # 2 Rd. (South)
Suite 5d, # 19, Lane 999
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Changzhou Orthmed Medical Instrument Co., Ltd.
Zhongshan # 2 Rd. (South)
Suite 5d, # 19, Lane 999
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/18/2010
Decision Date 11/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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