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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 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Lifeline Systems, Inc.
45 W. St.
Suite 2
North 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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