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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystourethroscope
510(k) Number K945185
Device Name CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
Applicant
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact MARIKA ANDERSON
Correspondent
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact Leigh Spotten
Regulation Number876.1500
Classification Product Code
FBO  
Date Received10/24/1994
Decision Date 05/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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