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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 K121311
Device Name THIXO-GEL ULTRASOUND SPRAY
Applicant
CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH
2670 LEAVENWORTH STREET
SAN FRANCISCO,  CA  94133
Applicant Contact CHRISTINA BERNSTEIN
Correspondent
CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH
2670 LEAVENWORTH STREET
SAN FRANCISCO,  CA  94133
Correspondent Contact CHRISTINA BERNSTEIN
Regulation Number892.1570
Classification Product Code
MUI  
Date Received05/01/2012
Decision Date 08/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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