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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Powered
510(k) Number K904796
Device Name MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T
Applicant
Personal Emergency Response System
119 Industrial Dr.
P.O. Box 431
East Longmeadow,  MA  01028
Applicant Contact ANDREW QUEEN
Correspondent
Personal Emergency Response System
119 Industrial Dr.
P.O. Box 431
East Longmeadow,  MA  01028
Correspondent Contact ANDREW QUEEN
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received10/23/1990
Decision Date 11/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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