SIMPLICITY DISPOSABLE PEN NEEDLE


definition

Device Classification Name

needle, hypodermic, single lumen

510(k) Number K002180
Device Name SIMPLICITY DISPOSABLE PEN NEEDLE
Original Applicant
STERLING MEDIVATIONS, INC.
180 ferndale rd. south
wayzata, 
MN 
55391

Original Contact joel douglas
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 07/19/2000
Decision Date 10/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Abbreviated
Reviewed by Third Party No

Combination Product

No