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FDA 510(k) Application Details - K172566
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K172566
Device Name
Hysteroscope (And Accessories)
Applicant
Hologic, Inc.
250 Campus Drive
Marlborough, MA 01752 US
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Contact
Catherine Sanford
Other 510(k) Applications for this Contact
Regulation Number
884.1690
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Classification Product Code
HIH
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More FDA Info for this Product Code
Date Received
08/25/2017
Decision Date
09/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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