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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 K030837
Device Name 40 L HIGH FLOW INSUFFLATOR F108
Applicant
W.O.M. World of Medicine AG
368 N. Asaph St.
Alexandria,  VA  22314
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. World of Medicine AG
368 N. Asaph St.
Alexandria,  VA  22314
Correspondent Contact SUSANNE RAAB
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/17/2003
Decision Date 02/05/2004
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
Predetermined Change
Control Plan Authorized		 No
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