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510(k) K223791

TalWire by Embrace Medical , Ltd. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2023
Date Received
December 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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