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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K950565
Device Name DEROYAL SURGICAL INSTRUMENT DRAPE
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/08/1995
Decision Date 12/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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