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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K150376
Device Name Sonoma Cancellous Bone Screw and Washer
Applicant
Sonoma Orthopedics Products, Inc.
3589 Westwind Blvd.
Santa Rosa,  CA  95403
Applicant Contact Rick Epstein
Correspondent
Memphis Regulatory Consulting, LLC
3416 Roxee Run Cove
Bartlett,  TN  38133
Correspondent Contact Dawn Norman
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received02/13/2015
Decision Date 06/12/2015
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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