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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K113424
Device Name LOFRIC SINGLE USE URINARY CATHETER
Applicant
Astra Tech AB
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Astra Tech AB
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number876.5130
Classification Product Code
EZD  
Date Received11/21/2011
Decision Date 04/17/2012
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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