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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K083582
Device Name SIGN HIP CONSTRUCT (SHC), MODEL: 701
Applicant
Surgical Implant Generation Network (Sign)
451 Hills St., Suite B
Richland,  WA  99354
Applicant Contact DOUGLAS J DONNELLY
Correspondent
Surgical Implant Generation Network (Sign)
451 Hills St., Suite B
Richland,  WA  99354
Correspondent Contact DOUGLAS J DONNELLY
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
HRS   HSB  
Date Received12/04/2008
Decision Date 08/26/2009
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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