J-FX CERCLAGE SYSTEM

Wire, Surgical

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for J-fx Cerclage System.

Pre-market Notification Details

Device IDK971682
510k NumberK971682
Device Name:J-FX CERCLAGE SYSTEM
ClassificationWire, Surgical
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJohn Ferros
CorrespondentJohn Ferros
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeLRN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-06
Decision Date1997-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295067740 K971682 000

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