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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Fistula
510(k) Number K023162
Device Name FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
Applicant
FRESENIUS MEDICAL CARE
95 HAYDEN AVE.
LEXINGTON,  MA  02420
Applicant Contact NICHOLE RIEK
Correspondent
FRESENIUS MEDICAL CARE
95 HAYDEN AVE.
LEXINGTON,  MA  02420
Correspondent Contact NICHOLE RIEK
Regulation Number876.5540
Classification Product Code
FIE  
Date Received09/23/2002
Decision Date 03/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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