FDA 510(k) Application Details - K031141

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

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510(K) Number K031141
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant ASAP ENDOSCOPIC PRODUCTS GMBH
KATHARINENSTR. 5
LUEBECK 23554 DE
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Contact MARTINA GUNDEROTH
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Regulation Number 876.1500

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Classification Product Code FAJ
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Date Received 04/10/2003
Decision Date 06/30/2003
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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