ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER


Device Classification Name

container, sharps

510(k) Number K081449
Device Name ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
Applicant
ULTIMED, INC.
5353 wayzata blvd.
suite 505
minneapolis, 
MN 
55416 -1334

Applicant Contact c. stamp
Regulation Number 880.5570
Classification Product Code
MMK  
Date Received 05/23/2008
Decision Date 06/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No