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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 K022449
Device Name HYSTEREOSCOPY PUMP HM4
Applicant
W.O.M. WORLD OF MEDICINE AG
91 TROWBRIDGE ST.
CAMBRIDGE,  MA  02138
Applicant Contact SUSANNE RAAB
Correspondent
W.O.M. WORLD OF MEDICINE AG
91 TROWBRIDGE ST.
CAMBRIDGE,  MA  02138
Correspondent Contact SUSANNE RAAB
Regulation Number884.1700
Classification Product Code
HIG  
Date Received07/26/2002
Decision Date 04/10/2003
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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