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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 K071809
Device Name ENSPLINTRX BONE FIXATION SYSTEM
Applicant
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Santa Rosa,  CA  95403
Applicant Contact CHARLES L NELSON
Correspondent
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Santa Rosa,  CA  95403
Correspondent Contact CHARLES L NELSON
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HSB  
Date Received07/02/2007
Decision Date 02/21/2008
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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