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U.S. Department of Health and Human Services

Device Classification under Section 513(f)(2)(de novo)

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Device Classification Name fetal head elevator
De Novo Number DEN150053
Device Name FETAL PILLOW
Requester
SAFE OBSTETRIC SYSTEMS LTD
berkeley townsend 150 hutton road
shenfield,  GB cm15 8nl
Contact rajiv varma
Regulation Number884.4350
Classification Product Code
PWB  
Date Received11/18/2015
Decision Date 07/27/2017
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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