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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 K062707
Device Name RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE
Applicant
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
731-733 SHOTGUN RD.
FT. LAUDERDALE,  FL  33326
Applicant Contact GERALD GOIGITZER
Correspondent
INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
731-733 SHOTGUN RD.
FT. LAUDERDALE,  FL  33326
Correspondent Contact GERALD GOIGITZER
Regulation Number876.1500
Classification Product Code
FGB  
Date Received09/11/2006
Decision Date 12/08/2006
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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