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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K982905
Device Name MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact KEVIN A KENNAN
Correspondent
Karl Storz Endoscopy- America, Inc.
2151 East Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Leigh A Spotten
Regulation Number876.1500
Classification Product Code
FGB  
Date Received08/18/1998
Decision Date 10/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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