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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 K963423
Device Name KSEA CO2 ENDOFLATOR
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact KEVIN A KENNAN
Correspondent
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact KEVIN A KENNAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/30/1996
Decision Date 05/27/1997
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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