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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Coupling, Ultrasound
510(k) Number K181363
Device Name EcoVue Sterile and Non-Sterile Ultrasound Gels
Applicant
H R Pharmaceuticals, Inc.
2600 Eastern Blvd., Suite 201
York,  PA  17402
Applicant Contact Colby Wiesman
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number892.1570
Classification Product Code
MUI  
Date Received05/23/2018
Decision Date 06/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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