NIPRO BIO-FLEX CATHETER


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K022756
Device Name NIPRO BIO-FLEX CATHETER
Original Applicant
NIPRO MEDICAL CORP.
1384 copperfield court
lexington, 
KY 
40514 -1268

Original Contact kaelyn b hadley
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 08/20/2002
Decision Date 10/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No