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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
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