K-numberK103128
Device nameCADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
ApplicantCadwell Lab, Inc.
Product codeETN
Device classClass II
Decision dateFeb 23, 2011
DecisionSubstantially Equivalent
Regulation874.1820
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