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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Galvanic Skin Response Measurement
510(k) Number K970436
Device Name E-READER
Applicant
NATURAL HERBAL PRODUCTS, INC.
724 WIGGINS BAY DR.
NAPLES,  FL  34110
Correspondent
NATURAL HERBAL PRODUCTS, INC.
724 WIGGINS BAY DR.
NAPLES,  FL  34110
Regulation Number882.1540
Classification Product Code
GZO  
Date Received02/05/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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