Quote:
Originally Posted by swatsurgeon
found the answer.....the fda did approve quik-clot but I could not find where wound stat had submitted for an "OK"....I need to search more before I label them a 'tag along' (get approved based on a similiar product without clinical research)
ss
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The 510(K) docuemnt for WoundStat can be found at:
http://www.fda.gov/cdrh/pdf7/K071936.pdf
It definitely looks like a "tag along" versus seperate approval for a new type of device.
Erik