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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 K871745
Device Name MODEL 26021C BIPOLAR COAGULATOR
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Applicant Contact NORMAN SILBERTRUST
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
10111 W. JEFFERSON BLVD.
CULVER CITY,  CA  90232 -3578
Correspondent Contact NORMAN SILBERTRUST
Regulation Number884.4150
Classification Product Code
HIN  
Date Received05/05/1987
Decision Date 07/10/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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