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FDA 510(k) Application Details - K143650
Device Classification Name
Culdoscope (And Accessories)
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510(K) Number
K143650
Device Name
Culdoscope (And Accessories)
Applicant
Cooper Surgical Inc.
95 Corporate Drive
Trumbull, CT 06611 US
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Contact
James Keller
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Regulation Number
884.1640
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Classification Product Code
HEW
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More FDA Info for this Product Code
Date Received
12/23/2014
Decision Date
07/21/2015
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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