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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K012374
Device Name MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
Applicant
ASTRA TECH, INC.
96 WEST MAIN ST.
NORTHBOROUGH,  MA  01532
Applicant Contact BRUCE R MANNING
Correspondent
ASTRA TECH, INC.
96 WEST MAIN ST.
NORTHBOROUGH,  MA  01532
Correspondent Contact BRUCE R MANNING
Regulation Number876.5130
Classification Product Code
GBM  
Date Received07/26/2001
Decision Date 08/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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