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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 K924523
Device Name HYS-SURGIFLATOR
Applicant
W.O.M. World of Medicine GmbH
C/O Qualitivity
8536 Calle Tioga
Tucson,  AZ  85704
Applicant Contact OWEN B LAMB
Correspondent
W.O.M. World of Medicine GmbH
C/O Qualitivity
8536 Calle Tioga
Tucson,  AZ  85704
Correspondent Contact OWEN B LAMB
Regulation Number884.1700
Classification Product Code
HIG  
Date Received09/08/1992
Decision Date 04/11/1995
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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