FDA 510(k) Application Details - K172962

Device Classification Name

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510(K) Number K172962
Device Name Nurture Rest
Applicant Neonatal Loving Kare, Inc.
1702 Treasure Lake
DuBois, PA 15801 US
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Contact Nicole Sawyers
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Regulation Number

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Classification Product Code OUW
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Date Received 09/26/2017
Decision Date 01/18/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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