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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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De Novo Number DEN240031
Device Name Prapela SVS hospital bassinet pad (model P01)
Requester
prapela, inc.
2 main st ste 15-219
biddeford,  ME  04005
Contact john konsin
Classification Product Code
QVY
Date Received06/17/2024
Decision Date 04/04/2025
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Direct
Predetermined Change
Control Plan Authorized		 No
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