FDA 510(k) Application Details - K231274

Device Classification Name

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510(K) Number K231274
Device Name Natural Cycles
Applicant Natural Cycles Nordic AB
St Eriksgatan 63b
Stockholm 112 34 SE
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Contact Raoul Scherwitzl, PhD
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Regulation Number

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Classification Product Code PYT
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Date Received 05/02/2023
Decision Date 08/24/2023
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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