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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 K914103
Device Name LIFELINE(R) PERSONAL RESPONSE SYSTEM
Applicant
LIFELINE SYSTEMS, INC.
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
LIFELINE SYSTEMS, INC.
45 WEST STREET, SUITE 2
ATTLEBORO,  MA  02703
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received09/12/1991
Decision Date 09/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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