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FDA 510(k) Application Details - K001270
Device Classification Name
Resectoscope
More FDA Info for this Device
510(K) Number
K001270
Device Name
Resectoscope
Applicant
GYRUS MEDICAL LTD.
FORTRAN RD., ST. MELLONS
CARDIFF CF3 0LT GB
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Contact
DAVID KAY
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FJL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/20/2000
Decision Date
04/28/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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