2005D-0019
BKG 1
Volume 1

Table of Contents

Reference 1 - 510(k) Manual - Premarkzt Notification 510(k): Regulatory Requirements for Medical Devices, August 1995; http://www.fda.gov/cdrh/manual/510kprt1.html

Reference 2 - The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Final Guidance, March 20, 1998; http://wvw.fda.gov/cdrh/ode/parad510.html

Reference 3 - The Least Burdensome Provisions - Activities Related to Implementation; http://ww.fda.gov/cdrh/modact/leastburdensome.html

Reference 4 - Guidance - Deciding When to Submit a 510(k) for a Change to an Existing Device, January 10, 1997; http://www.fda.gov/cdrh/ode/510kmod.html

Reference 5 - Guidance for Industry, Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods, January 2001; Technical Correction February 2001; http://www.fda.gov/cber/gdlns/rbcautoph2.htm

Reference 6 - Medical Device Reporting Guidance, Medical Device Reporting for Manufacturers, March 1997; http://www.fda.gov/cdrh/manual/mdrman.pdf