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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 K031014
Device Name HI-FLO THERME PNEU 45, WISAP #7083, 7083V
Applicant
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
RUDOLF-DIESEL-RING 20
SAUERLACH,  DE D-82054
Applicant Contact HORST SEMM
Correspondent
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
RUDOLF-DIESEL-RING 20
SAUERLACH,  DE D-82054
Correspondent Contact HORST SEMM
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/31/2003
Decision Date 06/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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