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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 K201299
Device Name HD Steth
Applicant
HD Medical, Inc.
3561 Homestead Road #146
Santa Clara,  CA  95051
Applicant Contact Stephanie Anderson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Codes
DPS   DQC  
Date Received05/15/2020
Decision Date 07/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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