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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K081832
Device Name ENSPLINTCMX CLAVICLE PIN
Applicant
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Suite C
Santa Rosa,  CA  95403
Applicant Contact CHARLES NELSON
Correspondent
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Suite C
Santa Rosa,  CA  95403
Correspondent Contact CHARLES NELSON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/27/2008
Decision Date 10/10/2008
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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