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FDA 510(k) Application Details - DEN170052
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170052
Device Name
Natural Cycles
Applicant
Natural Cycles Nordic AB
Luntmakargatan 26
Stockholm 111-37 SE
Other 510(k) Applications for this Company
Contact
Raoul Scherwitzl
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PYT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2017
Decision Date
08/10/2018
Decision
DENG -
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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