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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 K090975
Device Name DEROYAL NON-LOCKING BONE FIXATION 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 Received04/06/2009
Decision Date 04/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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