DigiGuide System

Driver, Wire, And Bone Drill, Manual

ProtoMED, Inc.

The following data is part of a premarket notification filed by Protomed, Inc. with the FDA for Digiguide System.

Pre-market Notification Details

Device IDK193499
510k NumberK193499
Device Name:DigiGuide System
ClassificationDriver, Wire, And Bone Drill, Manual
Applicant ProtoMED, Inc. 1329 W 121st Ave Westminster,  CO  80234
ContactJames Jimenez
CorrespondentRick Miller
ProtoMED, Inc. 1329 W 121st Ave Westminster,  CO  80234
Product CodeDZJ  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-11-04

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