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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 K140263
Device Name INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
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 Received02/03/2014
Decision Date 03/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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