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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 K090652
Device Name ALPHA DUO LAP INSUFFLATOR
Applicant
HIPPOKRATEC GMBH
AM WINDFELD 36
MIEBACH, BAVARIA,  DE 83714
Applicant Contact CHRISTIAN SIEDERSBERGER
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/11/2009
Decision Date 09/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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