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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K142962
Device Name PROTOCOL Incision Dressing
Applicant
Deroyal Industries
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact Elizabeth Wheeler
Correspondent
Deroyal Industries
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact Elizabeth Wheeler
Classification Product Code
FRO  
Date Received10/14/2014
Decision Date 07/23/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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