RESOLUT REGENERATIVE MATERIAL

Bone Grafting Material, Synthetic

W.L. GORE & ASSOCIATES,INC

The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Resolut Regenerative Material.

Pre-market Notification Details

Device IDK962624
510k NumberK962624
Device Name:RESOLUT REGENERATIVE MATERIAL
ClassificationBone Grafting Material, Synthetic
Applicant W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff,  AZ  86004
ContactJacqueline Kalbach
CorrespondentJacqueline Kalbach
W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff,  AZ  86004
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-05
Decision Date1996-10-03
Summary:summary

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