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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 K881902
Device Name HEALTHTRONIC OMEGA TRAC
Applicant
Healthtronics Surgical Services, Inc.
10619 Folsom Blvd.
Rancho Cordova,  CA  95670
Applicant Contact ANSEEUW, DC
Correspondent
Healthtronics Surgical Services, Inc.
10619 Folsom Blvd.
Rancho Cordova,  CA  95670
Correspondent Contact ANSEEUW, DC
Regulation Number890.5880
Classification Product Code
JFB  
Date Received05/06/1988
Decision Date 06/22/1988
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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