Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -13

Accepted - Volume 5

Comment Record
Commentor Mr. David Jagrosse Date/Time 2002-09-17 12:37:06
Organization Middlesex hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments It is my opinion that opened-but-unused, single use devices should be reprocessed by a third party reprocessor or hospital only with 510k approval for that item.




EC -13