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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 K043200
Device Name SIGN FIN NAIL
Applicant
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
2950 GEORGE WASHINGTON WAY
richland,  WA  99352 -1615
Applicant Contact douglas j donnelly
Correspondent
SURGICAL IMPLANT GENERATION NETWORK (SIGN)
2950 GEORGE WASHINGTON WAY
richland,  WA  99352 -1615
Correspondent Contact douglas j donnelly
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/18/2004
Decision Date 02/03/2005
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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