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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K896750
Device Name LOFRIC(R), LOFRIC(R) CATH-KIT
Applicant
ASTRA MEDITEC AB
P.O. BOX 14
S-4321 21 MOLNDAL
SWEDEN,  SE
Applicant Contact AGNETA SVENSSON
Correspondent
ASTRA MEDITEC AB
P.O. BOX 14
S-4321 21 MOLNDAL
SWEDEN,  SE
Correspondent Contact AGNETA SVENSSON
Regulation Number876.5130
Classification Product Code
KOD  
Date Received11/30/1989
Decision Date 08/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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