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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 K153367
Device Name S698 Symbioz flow
Applicant
SOPRO - ACTEON GROUP
ZAC ATHELIA IV AVENUE DES GENEVRIERS
LA CIOTAT,  FR 13705
Applicant Contact Philippe BOYER
Correspondent
ACTEON, INC.
555 Eleventh Street, NW
Suite 1000
Washington,  DC  20004 -1304
Correspondent Contact John R Manthei
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/23/2015
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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