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510(k) K120216

GENOSYL MV-1000 by Geno, LLC — Product Code MRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2012
Date Received
January 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Nitric Oxide Delivery
Device Class
Class II
Regulation Number
868.5165
Review Panel
AN
Submission Type

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