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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K861039
Device Name OMNIVAC (VACUUM ELECTRODE SYSTEM)
Applicant
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Applicant Contact JAMES BAUMANN
Correspondent
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Correspondent Contact JAMES BAUMANN
Regulation Number882.5890
Classification Product Code
LIH  
Date Received03/18/1986
Decision Date 09/26/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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