LORENZ BLUE DEVICE

External Mandibular Fixator And/or Distractor

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Blue Device.

Pre-market Notification Details

Device IDK020407
510k NumberK020407
Device Name:LORENZ BLUE DEVICE
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
ContactKim Reed
CorrespondentKim Reed
WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville,  FL  32218
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-06
Decision Date2002-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036157265 K020407 000
00841036010836 K020407 000
00841036010843 K020407 000
00841036010935 K020407 000
00841036010942 K020407 000
00841036010959 K020407 000
00841036057404 K020407 000
00841036057411 K020407 000
00841036075309 K020407 000
00841036092825 K020407 000
00841036157258 K020407 000
00841036075217 K020407 000

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