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Re: EDMGUY post# 38309

Tuesday, 11/22/2016 1:42:39 PM

Tuesday, November 22, 2016 1:42:39 PM

Post# of 97079
Ed,isn't your argument based on the assumption product/inventory itself was bad? Resulting from poor mfg'ing process or tooling?

How did you arrive to that conclusion?

From what information has been supplied by the Company(unless I missed something)the finger seems to point toward an FDA issue.

No? UDI issues.

And UDI Compliance has to do with Identification compliance.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/

Why is tooling being discussed?


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