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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K943007
Device Name ITP-HVPC GALVANIC STIMULATOR
Applicant
Innovative Therapy Products, Inc.
4004 St. Elizabeth
Kenner,  LA  70065
Applicant Contact WILLIAM G ROE
Correspondent
Innovative Therapy Products, Inc.
4004 St. Elizabeth
Kenner,  LA  70065
Correspondent Contact WILLIAM G ROE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/11/1994
Decision Date 10/26/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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