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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Vestibular Analysis
510(k) Number K922037
Device Name SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
Applicant
Micromedical Technologies, Inc.
110 W. Walnut
Chatham,  IL  62629
Applicant Contact RICHARD MILES, PH.D.
Correspondent
Micromedical Technologies, Inc.
110 W. Walnut
Chatham,  IL  62629
Correspondent Contact RICHARD MILES, PH.D.
Classification Product Code
LXV  
Date Received05/01/1992
Decision Date 10/26/1992
Decision Substantially Equivalent (SESE)
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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