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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stethoscope, Manual
510(k) Number K914100
Device Name STETHOSCOPE
Applicant
Atlas Medical Products, Inc.
5470-B Memorial Dr.
Stone Mountain,  GA  30083
Applicant Contact JEROME MOORE
Correspondent
Atlas Medical Products, Inc.
5470-B Memorial Dr.
Stone Mountain,  GA  30083
Correspondent Contact JEROME MOORE
Regulation Number870.1875
Classification Product Code
LDE  
Date Received09/12/1991
Decision Date 11/07/1991
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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