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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 K032777
Device Name MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
Applicant
Nipro Medical Corp.
510 Stonemont Dr.
Weston,  FL  33326
Applicant Contact RICHARD D BLISS
Correspondent
Nipro Medical Corp.
510 Stonemont Dr.
Weston,  FL  33326
Correspondent Contact RICHARD D BLISS
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/08/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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