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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urethrotome
510(k) Number K934730
Device Name KARL STORZ ENDOSCOPIC COLD KNIFE BLADES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact ROBERT R GIORGINI
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact ROBERT R GIORGINI
Regulation Number876.4770
Classification Product Code
EZO  
Date Received10/01/1993
Decision Date 01/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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