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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 K023704
Device Name KSEA SCB ACC 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  
Date Received11/04/2002
Decision Date 01/30/2003
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
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