CL UNIVERSAL HIP DEVICE

Prosthesis, Elbow, Hemi-, Radial, Polymer

LIMA INTL. CORP.

The following data is part of a premarket notification filed by Lima Intl. Corp. with the FDA for Cl Universal Hip Device.

Pre-market Notification Details

Device IDK885146
510k NumberK885146
Device Name:CL UNIVERSAL HIP DEVICE
ClassificationProsthesis, Elbow, Hemi-, Radial, Polymer
Applicant LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence,  RI  02915
ContactPollonio-lister
CorrespondentPollonio-lister
LIMA INTL. CORP. 392 WAMPANOAG TRAIL E Providence,  RI  02915
Product CodeKWI  
CFR Regulation Number888.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-15
Decision Date1989-04-24

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