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510(k) K232635

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) by Boston Scientific — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2023
Date Received
August 30, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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