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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 K033057
Device Name DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
Applicant
Deroyal
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact SHARON COOK
Correspondent
Deroyal
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact SHARON COOK
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/29/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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