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FDA 510(k) Application Details - K040215
Device Classification Name
Cystoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K040215
Device Name
Cystoscope And Accessories, Flexible/Rigid
Applicant
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
Other 510(k) Applications for this Company
Contact
PAMELA PAPINEAU
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FAJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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