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510(k) K163376

Mikro-Cath Pressure Catheter by Millar, Inc. — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2017
Date Received
December 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

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