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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, cranial electrotherapy
510(k) Number K883812
Device Name HP-1 (HEALTHPAX)
Original Applicant
post office box 874
morrisville,  PA  19067 0874
Original Contact stecker, phd
Regulation Number882.5800
Classification Product Code
Date Received09/08/1988
Decision Date 11/28/1988
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls