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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K894515
Device Name LISS CRANIAL STIMULATOR MODEL SBL201-M
Applicant
MEDICAL CONSULTANTS INTL. LTD.
59 OXFORD PLACE
GLEN ROCK,  NJ  07452
Applicant Contact SAUL LISS
Correspondent
MEDICAL CONSULTANTS INTL. LTD.
59 OXFORD PLACE
GLEN ROCK,  NJ  07452
Correspondent Contact SAUL LISS
Regulation Number882.5800
Classification Product Code
QJQ  
Date Received07/19/1989
Decision Date 05/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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