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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 K022632
Device Name SIGN IM NAIL
Applicant
Surgical Implant Generation Network (Sign)
2950 George Washington Way
Richland,  WA  99352 -1615
Applicant Contact DOUG DONNELLY
Correspondent
Surgical Implant Generation Network (Sign)
2950 George Washington Way
Richland,  WA  99352 -1615
Correspondent Contact DOUG DONNELLY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/07/2002
Decision Date 09/23/2002
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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