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FDA 510(k) Application Details - K143669
Device Classification Name
Catheter, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K143669
Device Name
Catheter, Assisted Reproduction
Applicant
MEDGYN PRODUCTS, INC.
100 W. Industrial Rd.
Addison, IL 60101 US
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Contact
AMAR AGADI
Other 510(k) Applications for this Contact
Regulation Number
884.6110
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Classification Product Code
MQF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/24/2014
Decision Date
11/23/2015
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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