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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 K102577
Device Name FORCE MEDICAL IM NAIL SYSTEM
Applicant
Force Medical, Inc.
3150 E. 200th. St.
Prior Lake,  MN  55372
Applicant Contact AL LIPPINCOTT
Correspondent
Force Medical, Inc.
3150 E. 200th. St.
Prior Lake,  MN  55372
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDS  
Date Received09/08/2010
Decision Date 05/03/2012
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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