FDA 510(k) Application Details - K954648

Device Classification Name Hysteroscope (And Accessories)

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510(K) Number K954648
Device Name Hysteroscope (And Accessories)
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 884.1690

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Classification Product Code HIH
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Date Received 10/10/1995
Decision Date 03/14/1996
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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