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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K880773
Device Name THE VENUS SYSTEM
Applicant
Neuroscientific Corp.
139 Florida St.
Farmingdale,  NY  11735
Applicant Contact ALAN P SCHWARTZ
Correspondent
Neuroscientific Corp.
139 Florida St.
Farmingdale,  NY  11735
Correspondent Contact ALAN P SCHWARTZ
Regulation Number882.1835
Classification Product Code
GWL  
Date Received02/26/1988
Decision Date 08/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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