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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K171139
Device Name LaparoLight Veress Needle
Applicant
Buffalo Filter, LLC
5900 Genesee Street
Lancaster,  NY  14086
Applicant Contact Kyrylo Shvetsov
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number884.1730
Classification Product Code
HIF  
Date Received04/18/2017
Decision Date 05/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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