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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 K771653
Device Name ELECTRONIC STETHOSCOPE
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number870.1875
Classification Product Code
DQD  
Date Received08/29/1977
Decision Date 09/12/1977
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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