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510(k) K231422

Precision GI by Limaca Medical, Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2023
Date Received
May 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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