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510(k) K231407

StarFin by Premium Medical Technology, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2023
Date Received
May 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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