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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K120156
Device Name PUREIMAGE ULTRASOUND TRANSMISSION GEL
Applicant
Medline
One Medline Place
Mundelein,  IL  60060
Applicant Contact MATT CLAUSEN
Correspondent
Medline
One Medline Place
Mundelein,  IL  60060
Correspondent Contact MATT CLAUSEN
Regulation Number892.1570
Classification Product Code
ITX  
Date Received01/18/2012
Decision Date 02/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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