Cytoflex Tefguard Ti-Enforced Membrane

Bone Grafting Material, Synthetic

Unicare Biomedical, Inc.

The following data is part of a premarket notification filed by Unicare Biomedical, Inc. with the FDA for Cytoflex Tefguard Ti-enforced Membrane.

Pre-market Notification Details

Device IDK151344
510k NumberK151344
Device Name:Cytoflex Tefguard Ti-Enforced Membrane
ClassificationBone Grafting Material, Synthetic
Applicant Unicare Biomedical, Inc. 23011 Moulton Parkway, J-11 Laguna Hills,  CA  92653
ContactStan Yang
CorrespondentStan Yang
Unicare Biomedical, Inc. 23011 Moulton Parkway, J-11 Laguna Hills,  CA  92653
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-19
Decision Date2015-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D767C0641010 K151344 000
D767C0639010 K151344 000
D767C0635010 K151344 000
D767C0617010 K151344 000
D767C0613010 K151344 000
D767C0609010 K151344 000

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