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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 K092731
Device Name VIBRO-TRAC
Applicant
Pneumex, Inc.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact JEAN ASQUITH
Correspondent
Pneumex, Inc.
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Correspondent Contact JEAN ASQUITH
Regulation Number890.5880
Classification Product Code
JFB  
Date Received09/04/2009
Decision Date 06/10/2010
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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