WIRE, GUIDE - MODIFICATION

Wire, Guide, Catheter

LAKE REGION MFG., INC.

The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Wire, Guide - Modification.

Pre-market Notification Details

Device IDK850828
510k NumberK850828
Device Name:WIRE, GUIDE - MODIFICATION
ClassificationWire, Guide, Catheter
Applicant LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska,  MN  55318
ContactJim Klosterman
CorrespondentJim Klosterman
LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska,  MN  55318
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-25
Decision Date1985-06-26

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