FDA 510(k) Application Details - K970892

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

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510(K) Number K970892
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant FIEGERT, INC.
TWO OAKWOOD BLVD. SUITE 160
HOLLYWOOD, FL 33020 US
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Contact ERNESTO HERNANDEZ
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Regulation Number 876.1500

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Classification Product Code FAJ
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Date Received 03/11/1997
Decision Date 05/05/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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