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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K031408
Device Name DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
Applicant
Deroyal
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact AUDREY DANIELS
Correspondent
Deroyal
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact AUDREY DANIELS
Regulation Number878.4040
Classification Product Code
FYA  
Date Received05/05/2003
Decision Date 10/15/2003
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
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