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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 K203511
Device Name Baby Gorilla/Gorilla Plating System
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Haylie Hertz
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Haylie Hertz
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received11/30/2020
Decision Date 12/29/2020
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
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