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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, ear, nose and throat
510(k) Number K042516
Device Name OTOMIMIX
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Applicant Contact KIM REED
Correspondent
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE,  FL  32218
Correspondent Contact KIM REED
Regulation Number872.3275
Classification Product Code
NEA  
Date Received09/16/2004
Decision Date 11/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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