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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 K063546
Device Name INSUFLOW DEVICE, MODEL 6198
Applicant
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL,  MN  55110
Applicant Contact DUANE LLOYD
Correspondent
LEXION MEDICAL, LLC.
5000 TOWNSHIP PKWY
ST. PAUL,  MN  55110
Correspondent Contact DUANE LLOYD
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/24/2006
Decision Date 01/10/2007
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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