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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 K011129
Device Name SIGN IM NAIL
Applicant
Sign, Inc.
2950 George Washington Way
Richland,  WA  99352
Applicant Contact JEANNE DILLNER
Correspondent
Sign, Inc.
2950 George Washington Way
Richland,  WA  99352
Correspondent Contact JEANNE DILLNER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/13/2001
Decision Date 07/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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