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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Central Control Unit
510(k) Number K080410
Device Name KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact SUSIE CHEN
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Correspondent Contact SUSIE CHEN
Regulation Number876.1500
Classification Product Code
ODA  
Date Received02/14/2008
Decision Date 04/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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