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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 K072515
Device Name EMBRACE GEL
Applicant
Orison Corporation
121 Boone Ridge Dr.
Johnson City,  TN  37601
Applicant Contact AL SANDY
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LOHTONEN
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/07/2007
Decision Date 09/20/2007
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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