FDA 510(k) Application Details - K992983

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

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510(K) Number K992983
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
1112 WESTON RD., SUITE 227
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 FAJ
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Date Received 09/03/1999
Decision Date 10/07/1999
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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