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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 K083358
Device Name LUBRICANO-ULTRASOUND
Applicant
FARCO PHARMA GMBH
555 ELEVENTH STREET NW
WASHINGTON,  DC  20004 -1304
Applicant Contact SETH A MAILHOT
Correspondent
FARCO PHARMA GMBH
555 ELEVENTH STREET NW
WASHINGTON,  DC  20004 -1304
Correspondent Contact SETH A MAILHOT
Regulation Number892.1570
Classification Product Code
MUI  
Date Received10/14/2008
Decision Date 01/09/2009
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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