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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K050169
Device Name HL 200 ELECTRONIC STETHOSCOPE
Applicant
Health & Life Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Health & Life Co., Ltd.
3892 S. America W. Trail
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.1875
Classification Product Code
DQD  
Date Received01/26/2005
Decision Date 04/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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