FDA 510(k) Application Details - K011876

Device Classification Name Insufflator, Hysteroscopic

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510(K) Number K011876
Device Name Insufflator, Hysteroscopic
Applicant CIRCON VIDEO
492 OLD CONNECTICUT PATH
FRAMINGHAM, MA 01701-4584 US
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Contact John DeLucia
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Regulation Number 884.1700

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Classification Product Code HIG
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Date Received 06/15/2001
Decision Date 01/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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