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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 K243399
Device Name Boehringer Laboratories Liver Retractor
Applicant
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Applicant Contact William Dackis
Correspondent
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Correspondent Contact William Dackis
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/31/2024
Decision Date 07/02/2025
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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