CMW CEMENT PRESSURISATION SYSTEM

K897134 · Dentsply Intl. · KIH · Mar 2, 1990 · Orthopedic

Device Facts

Record IDK897134
Device NameCMW CEMENT PRESSURISATION SYSTEM
ApplicantDentsply Intl.
Product CodeKIH · Orthopedic
Decision DateMar 2, 1990
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.4200
Device ClassClass 1

Regulatory Classification

Identification

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.

Innolitics

Panel 1

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