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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K020240
Device Name SLIM GLIDING NAIL SYSTEM
Applicant
Plus Orthopedics
6055 Lusk Blvd.
San Diego,  CA  92121 -2700
Applicant Contact HARTMUT LOCH
Correspondent
Plus Orthopedics
6055 Lusk Blvd.
San Diego,  CA  92121 -2700
Correspondent Contact HARTMUT LOCH
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/23/2002
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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