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510(k) K162640

iVitri EZ by Reprobitech Corp. — Product Code MQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2017
Date Received
September 22, 2016
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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