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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K021807
Device Name GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
Applicant
GRASS INSTRUMENT CO.
570 LIBERTY ST.
BRAINTREE,  MA  02185
Applicant Contact PETER L FULLER
Correspondent
GRASS INSTRUMENT CO.
570 LIBERTY ST.
BRAINTREE,  MA  02185
Correspondent Contact PETER L FULLER
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received06/03/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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