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510(k) K050197

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 by Minitube of America, Inc. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2006
Date Received
January 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

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