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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 K120640
FOIA Releasable 510(k) K120640
Device Name INSUFLOW SYNERGY PORT
Applicant
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL,  MN  55110
Applicant Contact BERNARD HORWATH
Correspondent
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL,  MN  55110
Correspondent Contact BERNARD HORWATH
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received03/02/2012
Decision Date 07/18/2012
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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