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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K853988
Device Name FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI
Applicant
FORAN INDUSTRIES, INC.
323 S. FRANKLIN ST.
SUITE B-292
CHICAGO,  IL  60606
Applicant Contact ROBERT J WAGNER
Correspondent
FORAN INDUSTRIES, INC.
323 S. FRANKLIN ST.
SUITE B-292
CHICAGO,  IL  60606
Correspondent Contact ROBERT J WAGNER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/27/1985
Decision Date 05/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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