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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K160684
Device Name Atteris No-Sting Skin Protectant
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
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/11/2016
Decision Date 07/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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