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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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301 to 310 of 429 results
Decision Date To: 05/26/2022
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Precision Flow® HVNI VAPOTHERM, INC. DEN170001 04/10/2018
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
PrimeStore MTM Longhorn Vaccines and Diagnostics LLC DEN170029 03/19/2018
PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. DEN090005 K082289 04/30/2010
Procise ADL ProciseDx Inc. DEN220023 09/29/2023
Procise IFX ProciseDx Inc. DEN210056 09/29/2023
ProdiGI Covidien LLC DEN220006 06/13/2022
PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
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