NIPRO SAFETOUCH HUBER INFUSTION SET


Device Classification Name

set, administration, intravascular

510(k) Number K081210
Device Name NIPRO SAFETOUCH HUBER INFUSTION SET
Applicant
NIPRO MEDICAL CORP.
3150 nw 107th ave.
miami, 
FL 
33172

Applicant Contact jessica oswald
Correspondent
NIPRO MEDICAL CORP.
3150 nw 107th ave.
miami, 
FL 
33172

Correspodent Contact jessica oswald
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 04/29/2008
Decision Date 10/21/2008
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

Recalls CDRH Recalls