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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 K983889
Device Name HYS-SURGIFLATOR 150P
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
194 BRANCH ST.
MANSFIELD,  MA  02048
Applicant Contact MICHAEL MCGRAIL
Correspondent
W.O.M. WORLD OF MEDICINE, GMBH
194 BRANCH ST.
MANSFIELD,  MA  02048
Correspondent Contact MICHAEL MCGRAIL
Regulation Number884.1700
Classification Product Code
HIG  
Date Received11/02/1998
Decision Date 01/14/1999
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
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