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510(k) K140207

RAPID-I KIT by Vitrolife Sweden AB — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2014
Date Received
January 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labware, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6160
Review Panel
OB
Submission Type

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