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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K894930
Device Name DENTEC 4000
Applicant
Dentec, Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact RODNEY MUNSEY
Correspondent
Dentec, Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact RODNEY MUNSEY
Regulation Number874.1820
Classification Product Code
ETN  
Date Received08/02/1989
Decision Date 03/27/1990
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
Predetermined Change
Control Plan Authorized		 No
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