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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 K030365
Device Name DEROYAL DRAPES, STERILE, NON-STERILE
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Applicant Contact AUDREY DANIELS
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Correspondent Contact AUDREY DANIELS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received02/04/2003
Decision Date 04/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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