FDA 510(k) Application Details - DEN170052

Device Classification Name

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510(K) Number DEN170052
Device Name Natural Cycles
Applicant Natural Cycles Nordic AB
Luntmakargatan 26
Stockholm 111-37 SE
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Contact Raoul Scherwitzl
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Regulation Number

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Classification Product Code PYT
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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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