FDA 510(k) Application Details - K062707

Device Classification Name Ureteroscope And Accessories, Flexible/Rigid

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510(K) Number K062707
Device Name Ureteroscope And Accessories, Flexible/Rigid
Applicant INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
731-733 SHOTGUN RD.
FT. LAUDERDALE, FL 33326 US
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Contact GERALD GOIGITZER
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Regulation Number 876.1500

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Classification Product Code FGB
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Date Received 09/11/2006
Decision Date 12/08/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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