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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 K896813
Device Name MODIFIED INTRAVENOUS CATHETER
Applicant
SAFEGUARD NEEDLE CO.
15847 WOODBINE CIRCLE
MUNDELEIN,  IL  60060
Applicant Contact MIKE MCDONALD
Correspondent
SAFEGUARD NEEDLE CO.
15847 WOODBINE CIRCLE
MUNDELEIN,  IL  60060
Correspondent Contact MIKE MCDONALD
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/04/1989
Decision Date 10/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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