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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 K910801
Device Name HIGH VOLTAGE PULSED GALVANIC STIMULATION APPLICATI
Applicant
Psychoenergetic Systems, Inc.
392 Marple Rd.
Broomall,  PA  19008
Applicant Contact STEPHEN BERLANT
Correspondent
Psychoenergetic Systems, Inc.
392 Marple Rd.
Broomall,  PA  19008
Correspondent Contact STEPHEN BERLANT
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/25/1991
Decision Date 09/04/1991
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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