FLEXTIME MAGNUM 360

Material, Impression

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Flextime Magnum 360.

Pre-market Notification Details

Device IDK003930
510k NumberK003930
Device Name:FLEXTIME MAGNUM 360
ClassificationMaterial, Impression
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl Zimmerman
CorrespondentCheryl Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-12-20
Decision Date2001-02-01

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