SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS


Device Classification Name

set, administration, intravascular

510(k) Number K011187
Device Name SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS
Original Applicant
STERLING MEDIVATIONS, INC.
180 ferndale rd. south
wayzata, 
MN 
55391

Original Contact joel douglas
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 04/18/2001
Decision Date 06/19/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Abbreviated
Reviewed by Third Party No

Combination Product

No