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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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Decision Date To: 06/03/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI INOVA DIAGNOSTICS, INC. DEN000007 K000732 08/16/2000
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE D QUICK-MED TECHNOLOGIES, INC. DEN070002 K060662 02/25/2009
QMS Plazomicin Immunoassay Microgenics Corporation DEN180030 11/19/2018
Q-Collar Q30 Sports Science, LLC DEN200017 02/26/2021
PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. DEN120011 K113070 07/10/2012
PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC DEN100016 K093579 04/27/2012
PROSTATE IMMOBILIZER RECTAL BALLOON RADIADYNE DEN130036 K132194 01/28/2014
PROLONG ERGON MEDICAL LTD. DEN130047 03/20/2015
ProdiGI Covidien LLC DEN220006 06/13/2022
Procise IFX ProciseDx Inc. DEN210056 09/29/2023
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