FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS


Device Classification Name

needle, fistula

510(k) Number K023162
Device Name FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
Original Applicant
FRESENIUS MEDICAL CARE
95 hayden ave.
lexington, 
MA 
02420

Original Contact nichole riek
Regulation Number 876.5540
Classification Product Code
FIE  
Date Received 09/23/2002
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