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FDA 510(k) Application Details - K170660
Device Classification Name
Hysteroscope (And Accessories)
More FDA Info for this Device
510(K) Number
K170660
Device Name
Hysteroscope (And Accessories)
Applicant
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 US
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Contact
Roaida Johnson
Other 510(k) Applications for this Contact
Regulation Number
884.1690
More FDA Info for this Regulation Number
Classification Product Code
HIH
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More FDA Info for this Product Code
Date Received
03/03/2017
Decision Date
07/13/2017
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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