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FDA 510(k) Application Details - K001590
Device Classification Name
Instrument, Manual, Specialized Obstetric-Gynecologic
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510(K) Number
K001590
Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant
UROGYN LTD.
34 FAIRWAY CIRCLE
NATICK, MA 01760 US
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Contact
KENNETH T BURCK
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Regulation Number
884.4530
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Classification Product Code
KNA
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More FDA Info for this Product Code
Date Received
05/17/2000
Decision Date
08/02/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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