is the precursor before the official release? http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?start_search=1&establishmentName=®Num=&StateName=&CountryName=&RegistrationNumber=&OwnerOperatorNumber=10040851&OwnerOperatorName=&ProductCode=&DeviceName=&ProprietaryName=&establishmentType