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EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 — E-Z-Em, Inc. (510(k) K031571)

EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 — E-Z-Em, Inc. (510(k) K031571) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825; Applicant: E-Z-Em, Inc.; Clearance track: 510(k).

Device nameEMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
ApplicantE-Z-Em, Inc.
Clearance track510(k)
Submission numberK031571
DecisionSubstantially Equivalent
Decision date2003-06-19
Date received2003-05-20
Product codeIZQ
Device class2
Medical specialtyCardiovascular
Applicant locationNY, US
SourceopenFDA device

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