FDA 510(k) Application Details - K962506

Device Classification Name Resectoscope

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510(K) Number K962506
Device Name Resectoscope
Applicant GYNECARE INNOVATION CENTER
1221 INNSBRUCK DR.
SUNNYVALE, CA 94089 US
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Contact MICHAEL A DANIEL
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Regulation Number 876.1500

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Classification Product Code FJL
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Date Received 06/27/1996
Decision Date 09/16/1996
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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