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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 K160192
Device Name Atteris Antimicrobial Skin & Wound Cleanser
Applicant
Rochal Industries, LLC
12719 Cranes Mill
San Antonio,  TX  78230
Applicant Contact WILLIAM J. COULSTON
Correspondent
Rochal Industries, LLC
12719 Cranes Mill
San Antonio,  TX  78230
Correspondent Contact WILLIAM J. COULSTON
Classification Product Code
FRO  
Date Received01/27/2016
Decision Date 07/28/2016
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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