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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 K092317
Device Name DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact GRACIE GREENWAY
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact GRACIE GREENWAY
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/04/2009
Decision Date 11/02/2009
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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