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FDA 510(k) Application Details - K191552
Device Classification Name
Media, Reproductive
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510(K) Number
K191552
Device Name
Media, Reproductive
Applicant
Hamilton Thorne Inc.
100 Cummings Center, Suite 465E
Beverly, MA 01915 US
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Contact
Donald Fournier
Other 510(k) Applications for this Contact
Regulation Number
884.6180
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Classification Product Code
MQL
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More FDA Info for this Product Code
Date Received
06/12/2019
Decision Date
09/18/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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