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510(k) K222184

Introducer Sheath Kits by Beijing Demax Medical Technology Co.,Ltd — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2023
Date Received
July 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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