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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 K974583
Device Name DEEGLITE
Applicant
GRASS-TELEFACTOR PRODUCT GROUP
1094 NEW DEHAVEN AVE.
WEST CONSHOHOCKEN,  PA  19428
Applicant Contact JAMES S BRYAN
Correspondent
GRASS-TELEFACTOR PRODUCT GROUP
1094 NEW DEHAVEN AVE.
WEST CONSHOHOCKEN,  PA  19428
Correspondent Contact JAMES S BRYAN
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Codes
DQA   GWQ  
Date Received11/18/1997
Decision Date 06/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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