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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K020640
Device Name KSEA SCB MEDIA CONTROL
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
5th Floor
Culver City,  CA  90230 -7600
Applicant Contact JAMES A LEE
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
5th Floor
Culver City,  CA  90230 -7600
Correspondent Contact JAMES A LEE
Regulation Number878.4580
Classification Product Code
FTA  
Subsequent Product Code
FET  
Date Received02/27/2002
Decision Date 05/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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