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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 K950035
Device Name SURGIFLATOR 20
Applicant
W.O.M. GMBH
PASCALSTRABE 11
BERLIN,  DE D-10587
Applicant Contact OWEN B LAMB
Correspondent
W.O.M. GMBH
PASCALSTRABE 11
BERLIN,  DE D-10587
Correspondent Contact OWEN B LAMB
Regulation Number884.1730
Classification Product Code
HIF  
Date Received01/04/1995
Decision Date 02/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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