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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 K151990
Device Name Tissue Removal System
Applicant
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Applicant Contact CHRIS RADL
Correspondent
Boehringer Laboratories, LLC
300 Thoms Dr.
Phoenixville,  PA  19460
Correspondent Contact CHRIS RADL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/20/2015
Decision Date 09/11/2015
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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