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Baxter Healthcare Ltd
Wallingford Road, Compton
Newbury, RG20 7QW
T:+44 (0) 1635 206 000
F:+44 (0) 1635 206 373
Baxter, Tisseel, Tissucol, Artiss, Duplospray, and Easyspray are trademarks of
Baxter International Inc., its subsidiaries or affiliates
UKI/128/19-0001 JXO\2019
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