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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 K981859
Device Name SURGIFLATOR-20 ECU
Applicant
W.O.M. World of Medicine GmbH
1775 I St., NW
Washington,  DC  20006 -2401
Applicant Contact ROBERT P REZNICK
Correspondent
W.O.M. World of Medicine GmbH
1775 I St., NW
Washington,  DC  20006 -2401
Correspondent Contact ROBERT P REZNICK
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/27/1998
Decision Date 06/26/1998
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
Predetermined Change
Control Plan Authorized		 No
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