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FDA 510(k) Application Details - K051160
Device Classification Name
Culdoscope (And Accessories)
More FDA Info for this Device
510(K) Number
K051160
Device Name
Culdoscope (And Accessories)
Applicant
INSITU SYSTEMS
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact
MARY MCNAMARA-CULLINANE
Other 510(k) Applications for this Contact
Regulation Number
884.1640
More FDA Info for this Regulation Number
Classification Product Code
HEW
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More FDA Info for this Product Code
Date Received
05/05/2005
Decision Date
09/02/2005
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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