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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Assisted Reproduction
510(k) Number K050197
Device Name MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
Applicant
Minitube of America, Inc.
One E. Main St., Suite 300
Madison,  WI  53703
Applicant Contact FREDERICK T RIKKERS
Correspondent
Minitube of America, Inc.
One E. Main St., Suite 300
Madison,  WI  53703
Correspondent Contact FREDERICK T RIKKERS
Regulation Number884.6120
Classification Product Code
MQG  
Date Received01/27/2005
Decision Date 10/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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