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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 K150569
Device Name LaparoVue
Applicant
Buffalo Filter, LLC
5900 Genesee St.
Lancaster,  NY  14086
Applicant Contact Pamela Netzel
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plaza, Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
OCT  
Date Received03/06/2015
Decision Date 06/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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