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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bur, ear, nose and throat
510(k) Number K935584
Device Name MEDNEXT BUR
Applicant
MEDNEXT, INC.
3878 PROSPECT AVENUE, SUITE 24
WEST POINT BEACH,  FL  33404
Applicant Contact THOMAS J MICKEL, PH.D.
Correspondent
MEDNEXT, INC.
3878 PROSPECT AVENUE, SUITE 24
WEST POINT BEACH,  FL  33404
Correspondent Contact THOMAS J MICKEL, PH.D.
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received11/18/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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