OTOMIMIX

Cement, Ear, Nose And Throat

WALTER LORENZ SURGICAL, INC.

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

Pre-market Notification Details

Device IDK042516
510k NumberK042516
Device Name:OTOMIMIX
ClassificationCement, Ear, Nose And Throat
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 CodeNEA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-16
Decision Date2004-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841036141943 K042516 000
00888233025201 K042516 000

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