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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 K971549
Device Name VMT SYSTEM
Applicant
TARGET HEALTH, INC.
310 MADISON AVE.
22ND FLOOR
NEW YORK,  NY  10017
Applicant Contact JULES T MITCHEL
Correspondent
TARGET HEALTH, INC.
310 MADISON AVE.
22ND FLOOR
NEW YORK,  NY  10017
Correspondent Contact JULES T MITCHEL
Classification Product Code
LXV  
Date Received04/28/1997
Decision Date 10/05/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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