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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 K130041
Device Name SHEATHES STERILE ULTRASOUND GEL
Applicant
Sheathing Technologies, Inc.
18431 Technology Dr.
Morgan Hill,  CA  95037
Applicant Contact JENNIFER DOWNING
Correspondent
Sheathing Technologies, Inc.
18431 Technology Dr.
Morgan Hill,  CA  95037
Correspondent Contact JENNIFER DOWNING
Regulation Number892.1570
Classification Product Code
MUI  
Date Received01/08/2013
Decision Date 02/06/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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