New White Paper Describes babyLance Safety Heelstick 510(k) Application Process
Summary
" "Specifically, the cleared indications for use are that the babyLance is an incision device to obtain a blood sample from the heel of newborn and preemie infants," said MediPurpose founder and CEO Patrick Yi." To date, babyLance is believed to be the only infant heelstick device marketed in the United States with 510(k) clearance for sharps prevention features.For more information about MediPurposes medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com.Atlanta, GA, April 05, 2013 --( PR.com )-- MediPurpose(tm), a manufacturer and master distributor of medical products, today announced the publication of a new white paper, “Reinventing a Better Safety Heelstick: Obtaining U.S. FDA 510(k) for Sharps Prevention Features.”The white paper illustrates:* The meaning and significance of a 510(k) for medical devices with sharps injury prevention features.""Specifically, the cleared indications for use are that the babyLance is an incision device to obtain a blood sample from the heel of newborn and preemie infants," said MediPurpose founder and CEO Patrick Yi.