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KingKong_Guru

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KingKong_Guru

Re: KingKong_Guru post# 29080

Saturday, 10/09/2010 2:59:47 AM

Saturday, October 09, 2010 2:59:47 AM

Post# of 59551
One more RED took 311 days ...



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=32070
//
Regulation Number 892.1680
Classification Product Code
KPR
Date Received 09/14/2009
Decision Date 07/21/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
//

This device is also not new device ..

FDA is really very careful in approving RED's ...but finally these device are getting SE..



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