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FDA 510(k) Application Details - K180552
Device Classification Name
Catheters, Salpingography
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510(K) Number
K180552
Device Name
Catheters, Salpingography
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington, IN 47402 US
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Contact
Naomi Funkhouser
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Regulation Number
000.0000
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Classification Product Code
MOV
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More FDA Info for this Product Code
Date Received
03/01/2018
Decision Date
07/12/2018
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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