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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 K050874
Device Name ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
Applicant
Astra Tech, Inc.
20 Main St.
Northborough,  MA  01532
Applicant Contact BRUCE R MANNING
Correspondent
Astra Tech, Inc.
20 Main St.
Northborough,  MA  01532
Correspondent Contact BRUCE R MANNING
Regulation Number876.5130
Classification Product Code
GBM  
Date Received04/06/2005
Decision Date 05/05/2005
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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