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Yes, QuikClot received 510(k) clearance from FDA to market QuikClot over the counter (NON-prescriptive) in March of 2002. The 510(k) number is k013390, and you can view the FDA decision at the following website by plugging in the 510(k) number: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.
