SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS


Device Classification Name

set, administration, intravascular

510(k) Number K021216
Device Name SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
Original Applicant
STERLING MEDIVATIONS, INC.
66 neptune dr.
groton, 
CT 
06340

Original Contact joel douglas
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 04/17/2002
Decision Date 05/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No