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Merit Medical Systems,
Inc.
MMSI, a leading manufacturer and marketer of proprietary
disposable devices used primarily in cardiology, radiology and endoscopy,
today announced that it has received 510(k) clearance from the Food and Drug
Administration to market the Merit Laureate® hydrophilic guide wire.
In February 2012, Merit Medical received a warning letter from the FDA
regarding modifications in the manufacturing process for which the FDA
required additional information. Merit complied by filing a new 510(k)
submission.
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