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510(k) K081116

G-IVF G5 SERIES by Vitrolife Sweden AB — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2008
Date Received
April 18, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

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