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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K140099
Device Name LIGHTHOUSE URINARY CATHETER
Applicant
SEEDINGS LIFE SCIENCE VENTURES, LLC
230 EAST 15TH STREET
SUITE 1-A
NEW YORK,  NY  10003
Applicant Contact KEN SOLOVAY
Correspondent
SEEDINGS LIFE SCIENCE VENTURES, LLC
230 EAST 15TH STREET
SUITE 1-A
NEW YORK,  NY  10003
Correspondent Contact KEN SOLOVAY
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
FGI  
Date Received01/16/2014
Decision Date 03/04/2014
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
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