MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

Accessory, Assisted Reproduction

MINITUBE OF AMERICA, INC

The following data is part of a premarket notification filed by Minitube Of America, Inc with the FDA for Minitube Temperature Control Unit Sc-2000 + 2045.

Pre-market Notification Details

Device IDK050197
510k NumberK050197
Device Name:MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
ClassificationAccessory, Assisted Reproduction
Applicant MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 Madison,  WI  53703
ContactFrederick T Rikkers
CorrespondentFrederick T Rikkers
MINITUBE OF AMERICA, INC ONE EAST MAIN STREET, STE 300 Madison,  WI  53703
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-27
Decision Date2006-10-06

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