FDA 510(k) Application Details - K001270

Device Classification Name Resectoscope

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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
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Regulation Number 876.1500

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Classification Product Code FJL
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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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