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FDA 510(k) Application Details - K050197
Device Classification Name
Accessory, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K050197
Device Name
Accessory, Assisted Reproduction
Applicant
MINITUBE OF AMERICA, INC
ONE EAST MAIN STREET, STE 300
MADISON, WI 53703 US
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Contact
FREDERICK T RIKKERS
Other 510(k) Applications for this Contact
Regulation Number
884.6120
More FDA Info for this Regulation Number
Classification Product Code
MQG
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More FDA Info for this Product Code
Date Received
01/27/2005
Decision Date
10/06/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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