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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 K830196
Device Name CORSTREN COMPRESSION TUBE & PLATE
Applicant
Zimmer, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Zimmer, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3030
Classification Product Code
KTT  
Date Received01/20/1983
Decision Date 03/25/1983
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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