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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Aid, Cardiopulmonary Resuscitation
510(k) Number K954692
Device Name CPR PROMPT
Applicant
County Line , Ltd.
4543 Taylor Ln.
Warrensville,  OH  44128
Applicant Contact TERRY G MAHN
Correspondent
County Line , Ltd.
4543 Taylor Ln.
Warrensville,  OH  44128
Correspondent Contact TERRY G MAHN
Regulation Number870.5210
Classification Product Code
LIX  
Date Received10/11/1995
Decision Date 03/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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