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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 K861365
Device Name FASICULATED NAIL
Applicant
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact JIM KLOSTERMAN
Correspondent
Lake Region Mfg., Inc.
340 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact JIM KLOSTERMAN
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/11/1986
Decision Date 05/06/1986
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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