manufacturing practice requirements / marketed predicate devices / manufacturing practice / announcements concerning your device / predicate devices / /
Organization
New Hampshire Avenue Document Mail Center / THE NETHERLANDS Food and Drug Administration / Division of Postmarket Surveillance / Division of Small Manufacturers / International and Consumer Assistance / Division of Reproductive / Gastra-Renal / and Uralogical Devices / DEPARtMENT OF HEALTH / Center for Devices and Radiological Health / Gastro-Renal and Urological Devices Office / CDRH's office of Surveillance / office of Device Evaluation / /
(4D(vio 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Date: MAR