FDA 510(k) Application Details - K040215

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

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510(K) Number K040215
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 876.1500

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Classification Product Code FAJ
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Date Received 01/30/2004
Decision Date 04/15/2004
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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