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510(k) K242541

GEM ZIPCLIP by Synovis Micro Companies Alliance A Subsidiary of Baxter Int — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2025
Date Received
August 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

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