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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 K871247
Device Name KRONNER UNIVERSAL FRAME EXTERNAL FIXATION
Applicant
KRONNER MEDICAL
544 WEST UMPQUA
SUITE 104
ROSEBURG,  OR  97470
Applicant Contact CRYSTAL KRONNER
Correspondent
KRONNER MEDICAL
544 WEST UMPQUA
SUITE 104
ROSEBURG,  OR  97470
Correspondent Contact CRYSTAL KRONNER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/30/1987
Decision Date 05/22/1987
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
Recalls CDRH Recalls
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