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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 K132203
Device Name PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
Applicant
LEXION MEDICAL, LLC.
4486 TIMBERLINE CT
VADNAIS HEIGHTS,  MN  55127
Applicant Contact BERNARD HORWATH
Correspondent
LEXION MEDICAL, LLC.
4486 TIMBERLINE CT
VADNAIS HEIGHTS,  MN  55127
Correspondent Contact BERNARD HORWATH
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received07/16/2013
Decision Date 09/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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