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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name coagulator-cutter, endoscopic, bipolar (and accessories)
510(k) Number K122983
Device Name KSEA BIPOLAR ELECTRODE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO,  CA  90245
Applicant Contact WINKIE WONG
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO,  CA  90245
Correspondent Contact WINKIE WONG
Regulation Number884.4150
Classification Product Code
HIN  
Date Received09/26/2012
Decision Date 06/26/2013
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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