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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K842648
Device Name GENERAL SURGERY TRAY
Applicant
DEROYAL INDUSTRIES, INC.
Powell,  TN  37849
Applicant Contact Sarah Bennett
Correspondent
DEROYAL INDUSTRIES, INC.
Powell,  TN  37849
Correspondent Contact Sarah Bennett
Regulation Number878.4370
Classification Product Code
LRO  
Date Received08/13/1984
Decision Date 09/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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