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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 K060723
Device Name 40 L HIGH FLOW INSUFFLATOR F113
Applicant
W.O.M. World of Medicine AG
1490 Cambridge St.
Cambridge,  MA  02139
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. World of Medicine AG
1490 Cambridge St.
Cambridge,  MA  02139
Correspondent Contact SUSANNE RAAB
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
GCJ  
Date Received03/17/2006
Decision Date 05/25/2006
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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