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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K911416
Device Name ELITE SYSTEM
Applicant
Gfb Intl. Trading, Inc.
46 Trinity Pl.
New York,  NY  10006
Applicant Contact PAULSEN VANDEVERT
Correspondent
Gfb Intl. Trading, Inc.
46 Trinity Pl.
New York,  NY  10006
Correspondent Contact PAULSEN VANDEVERT
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received04/01/1991
Decision Date 06/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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