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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 K962863
Device Name KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact RENATE M MACLAREN
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact RENATE M MACLAREN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received07/23/1996
Decision Date 11/19/1996
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
Predetermined Change
Control Plan Authorized		 No
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