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510(k) K193507

Merit ONE Snare System by Merit Medical Systems, Inc. — Product Code MMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
December 18, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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  • K200268 — Halo™ Single-Loop Snare Kit (June 3, 2020)
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