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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 K031321
Device Name LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
Applicant
MEDLOGIC GLOBAL LIMITED
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON,  GB PL7 5BG
Applicant Contact MEL LONGHURST
Correspondent
MEDLOGIC GLOBAL LIMITED
WESTERN WOOD WAY
LANGAGE SCIENCE PARK
PLYMOUTH, DEVON,  GB PL7 5BG
Correspondent Contact MEL LONGHURST
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/25/2003
Decision Date 01/21/2004
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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