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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 K933196
Device Name THE SIGNATURE SERIES, IC II
Applicant
Progressive Electrical Therapeutics
122 W. Walnut
Nevada,  MO  64772
Applicant Contact GARY HUDDLESTON
Correspondent
Progressive Electrical Therapeutics
122 W. Walnut
Nevada,  MO  64772
Correspondent Contact GARY HUDDLESTON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/01/1993
Decision Date 07/12/1994
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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