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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K252957
Device Name Pneumo Dissector Hook
Applicant
Ab Medica Sas
Les Petites Quarterees, Mery Sur-Cher
Centre-Val De Loire,  FR 18100
Applicant Contact Alexandre Blanc
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/16/2025
Decision Date 01/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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