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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 K012976
Device Name TWIN PLUS
Applicant
GRASS-TELEFACTOR DIVISON
WEST-WARWICK,  RI  02893
Applicant Contact JOHN B CHATTEN
Correspondent
GRASS-TELEFACTOR DIVISON
WEST-WARWICK,  RI  02893
Correspondent Contact JOHN B CHATTEN
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received09/05/2001
Decision Date 02/12/2002
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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