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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Jelly, Lubricating, For Transurethral Surgical Instrument
510(k) Number K081990
Device Name LUBRICANO STERILE GEL
Applicant
Farco Pharma GmbH
555 Eleventh St., NW
Washington,  DC  20004 -1304
Applicant Contact SETH A MAILHOT
Correspondent
Farco Pharma GmbH
555 Eleventh St., NW
Washington,  DC  20004 -1304
Correspondent Contact SETH A MAILHOT
Regulation Number876.1500
Classification Product Code
FHX  
Date Received07/14/2008
Decision Date 12/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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