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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K200834
Device Name Lever Action Plate System
Applicant
Mcginley Orthpaedic Innovations, LLC
2435 King Blvd. #230
Casper,  WY  82604
Applicant Contact Adam M. Johnson
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact David McGurl
Regulation Number888.3030
Classification Product Code
HRS  
Date Received03/30/2020
Decision Date 06/25/2020
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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