inflation device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / announcements concerning your device / predicate devices / Internet address htp/wwfagvMdcleie/eorefro/nu~ydfuthm Sincerely / /
Organization
FDA / Division of Postmarket Surveillance / Cardiovascular Devices Office / Device Evaluation Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / DEPARTMENT OF HEALTH &HUMAN SERVICES and Drug Administration / office of Device Evaluation / Division of Cardiovascular Devices / /
Person
Suzanne Redman / Silver Spring / D. Zuckerman / Collapse Kink / / /
SECTION[removed]k) SUMMARY -MAR -6 The 5 10(k) Summary is submitted in accordance with 21 CER[removed]and the requirements of the Safe Medical Device Act (SMDA) of 1990.