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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, unipolar (and accessories)
510(k) Number K944862
Device Name KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
91 CARPENTER HILL RD.
CHARLTON,  MA  01507 -3578
Applicant Contact BETTY M JOHNSON
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
91 CARPENTER HILL RD.
CHARLTON,  MA  01507 -3578
Correspondent Contact BETTY M JOHNSON
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Code
HET  
Date Received10/03/1994
Decision Date 02/09/1995
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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