SAFESTEP MAX POWER-INJECTABLE INFUSION SET


Device Classification Name

set, administration, intravascular

510(k) Number K073050
Device Name SAFESTEP MAX POWER-INJECTABLE INFUSION SET
Applicant
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
585 west 500 south
bountiful, 
UT 
84010

Applicant Contact mark nelson
Correspondent
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
585 west 500 south
bountiful, 
UT 
84010

Correspodent Contact mark nelson
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 10/29/2007
Decision Date 01/25/2008
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