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510(k) K240057

TraumaGuard Intra-abdominal Pressure Sensing System by Sentinel Medical Technologies, LLC — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2024
Date Received
January 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Sentinel Medical Technologies, LLC

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