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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K981511
Device Name OTO WIZZARD
Applicant
Medrx, Inc.
7777 131st St., Suite 6
Seminole,  FL  33776
Applicant Contact JEFFREY A MCLAUGHLIN
Correspondent
Medrx, Inc.
7777 131st St., Suite 6
Seminole,  FL  33776
Correspondent Contact JEFFREY A MCLAUGHLIN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received04/28/1998
Decision Date 07/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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