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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K080554
Device Name INAREX, MODEL 2D-LX
Applicant
Inarex Corporation
Flemington Ct. # 155
La Mirada,  CA  90638
Applicant Contact BRANDON CHOI
Correspondent
Inarex Corporation
Flemington Ct. # 155
La Mirada,  CA  90638
Correspondent Contact BRANDON CHOI
Regulation Number890.5880
Classification Product Code
JFB  
Date Received02/28/2008
Decision Date 08/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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