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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 K133443
Device Name MARATHON NO STING LIQUID SKIN PROTECTANT
Applicant
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON,  GB PL7 5BG
Applicant Contact ROSE GUANG
Correspondent
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON,  GB PL7 5BG
Correspondent Contact ROSE GUANG
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/12/2013
Decision Date 07/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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