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510(k) K192146

V-DENUPET by Vitromed GmbH — Product Code MQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2020
Date Received
August 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microtools, Assisted Reproduction (Pipettes)
Device Class
Class II
Regulation Number
884.6130
Review Panel
OB
Submission Type

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