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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 K132204
Device Name 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 Received07/16/2013
Decision Date 08/22/2013
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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