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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Documentation, Breast Lesion
510(k) Number K181672
Device Name SureTouch Mobile Pressure Mapping System
Applicant
Sure, Inc.
1404 Granvia Altamira
Palos Verdes Estates,  CA  90274
Applicant Contact David Ables
Correspondent
Certified Compliance Solutions
11665 Avena Pl. Suite 203
San Diego,  CA  92128
Correspondent Contact Laurence Harvey
Regulation Number884.2990
Classification Product Code
NKA  
Date Received06/25/2018
Decision Date 06/28/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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