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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K934866
Device Name HYS-SURGIMAT
Applicant
W.O.M. World of Medicine GmbH
1300 I St., NW
Suite 900 W.
Washington,  DC  20005
Applicant Contact E KEEFER
Correspondent
W.O.M. World of Medicine GmbH
1300 I St., NW
Suite 900 W.
Washington,  DC  20005
Correspondent Contact E KEEFER
Regulation Number884.1700
Classification Product Code
HIG  
Date Received10/12/1993
Decision Date 10/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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